Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors

Sponsor

Athenex, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04878484

Collaborator

(none)

Enrollment

Location

Arms

39.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.

This study will investigate the safety, tolerability, activity, and pharmacokinetics/ pharmacodynamics of TCRT-ESO-A2 infusion. A maximum tolerated dose study of TCRT-ESO-A2 in subjects with advanced malignancies expressing NY-ESO-1 is considered to be an acceptable risk. Once safety, tolerability, and pharmacokinetic/pharmacodynamic data are available, the activity of TCRT-ESO-A2 in NY-ESO-1-positive tumors may be explored further.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Biological: TCRT-ESO-A2	Phase 1

Detailed Description

This is a Phase 1 open-label, multi-site, "3+3" dose escalation, study to evaluate the maximum tolerated dose, safety and tolerability, of TCRT-ESO-A2 suspension for IV infusion. Approximately 24 HLA-A*0201-positive subjects with head and neck cancer, hepatocellular carcinoma, lung squamous cell carcinoma, synovial sarcoma, and triple-negative breast cancer expressing NY-ESO-1 who have received at least first-line therapy for their cancer, or which there is no accepted therapy will be enrolled. Tumor tissue samples will be evaluated and scored using the NY-ESO-1 IHC assay developed specifically to support this study.

Following screening and enrollment (approximately Days -63 to -36) subjects will undergo leukapheresis for T cell collection at approximately Day -35 (Figure 3). Harvested cells will be fractionated, genetically engineered, and expanded ex vivo to produce autologous TCRT-ESO-A2 TCR-T. Following TCRT-ESO-A2 product release, subjects will receive a 3-day, non-myeloablative lymphodepletion regimen of fludarabine/cyclophosphamide from approximately Days -5 to -3 (recommend Wednesday to Friday) to prime the subject for immune re-population. Subjects will receive their TCRT-ESO-A2 cell product on Day 1 (recommend Monday) as an IV infusion over approximately 30 minutes. Within 30 minutes after completion of TCRT-ESO-A2 infusion, low dose subcutaneous aldesleukin (rhIL-2) will be administered at 500,000 IU BID daily for 14 days.

Dose escalation will be divided into three dose groups of three subjects each, with doses calculated as the number of TCR Vβ8-positive cells (total TCRT-ESO-A2 dose), with an allowable variance in cell count of ±30%. Escalation to higher doses will be based on the safety and tolerability of the previous cohort evaluated. If dose-limiting toxicity is observed in one subject at a dose level, up to an additional three dose limiting toxicity-evaluable subjects will be enrolled at that dose level. Subjects will be evaluated for dose limiting toxicity up to 28 days post-TCRT-ESO-A2 infusion. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to 28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity.

Three dose groups of subjects will be enrolled:

Cohort 1: 0.3 × 1010 TCRT-ESO-A2 cells* Cohort 2: 1.0 × 1010 TCRT-ESO-A2 cells* Cohort 3: 3.0 × 1010 TCRT-ESO-A2 cells*

±30% Subjects will be monitored daily during in-patient hospitalization for 5 days post dose. Subjects will then visit an out-patient clinic weekly during the Dose Limiting Toxicity Evaluation Period of 4 weeks and followed at approximately Days 60, 90, and every 3 months until confirmation of disease progression. Disease monitoring will be conducted by Magnetic Resonance Imaging or Computed Tomography scan (as appropriate for disease), during screening (if recent scans are not available), during lead-in approximately 7 days prior to TCRT-ESO-A2 infusion, at approximately Days 28, 60, 90, and every 3 months until confirmation of disease progression. If subjects remain clinically stable, confirmation of progression may be assessed 4- to 8-weeks later. Positron emission tomography scanning may be used as appropriate as an adjunct. Tumor biopsies will be taken from non-target lesions, if accessible, at baseline, approximately Days 28, 90, 180, and upon progression. Ascites/pleural fluid may be collected in addition to biopsies for correlative research studies if the subject requires paracentesis or pleuracentesis. At progression, long term follow-up will commence. During long term follow-up, subjects will be followed twice yearly for up to 5 years post-infusion and then annually for up to 15 years.

Timing of tumor and liquid biopsies may be adjusted as may the timing of other procedures or safety studies. In addition, up to 150 additional mL of blood may be collected over a three-month period without amendment of the protocol. Additional safety measures may be included, and tests may be done at any time if clinically indicated. In addition, if objective responses are observed in tumors after the safety of each cohort has been evaluated, up to 12 additional subjects with that tumor type (up to 2 tumor types) may be enrolled to further explore the tumor response rate in that tumor type.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

open-label, multi-site, "3+3" dose escalation studyopen-label, multi-site, "3+3" dose escalation study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, and Activity of TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: TCRT-ESO-A2: 0.3 × 1010 TCRT-ESO-A2 cells * ±30% Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.	Biological: TCRT-ESO-A2 TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.
Experimental: Cohort 2: TCRT-ESO-A2: 1.0 × 1010 TCRT-ESO-A2 cells ±30% Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor.	Biological: TCRT-ESO-A2 TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.
Experimental: Cohort 3: TCRT-ESO-A2 : 3.0 × 1010 TCRT-ESO-A2 cells ±30% Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.	Biological: TCRT-ESO-A2 TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.

Arm

Intervention/Treatment

Experimental: Cohort 1: TCRT-ESO-A2: 0.3 × 1010 TCRT-ESO-A2 cells * ±30%

Subjects will be evaluated for DLTs up to 28 days post-TCRT-ESO-A2 infusion. Enrollment into a dose level will be suspended if two of no more than six subjects at a dose level experience dose-limiting toxicity. Prior to increasing the dose, a cohort management meeting will be held after the final enrolled subject has been followed for up to28 days. The decision to increase to the next dose level will be a joint decision of the clinical site Investigators and Sponsor. At each cohort, there will be at least 7 days between infusion of each subject in the cohort.

Biological: TCRT-ESO-A2

Experimental: Cohort 2: TCRT-ESO-A2: 1.0 × 1010 TCRT-ESO-A2 cells ±30%

Biological: TCRT-ESO-A2

Experimental: Cohort 3: TCRT-ESO-A2 : 3.0 × 1010 TCRT-ESO-A2 cells ±30%

Biological: TCRT-ESO-A2

Outcome Measures

Primary Outcome Measures

Dose Escalation: Evaluate up to Eighteen Subjects With Tumors Expressing TCRT-ESO-A1 and Having Dose Limiting Toxicity Adverse Events as Assessed by CTCAE-Version 5 [Day 28]
TCRT-ESO-A2 maximum tolerated dose as assessed by the occurrence of dose-limiting toxicity adverse events at least possibility related to TCRT-ESO - A2 in two of six subjects who received TCRT-ESO-A2

Secondary Outcome Measures

Dose Escalation: Abnormal Heart Rate Measurement Assessment [Baseline to disease progression, averaging one year]
Evaluate heart rate as assessed by clinically significant abnormal heart rate measurement changes from baseline
Dose Escalation: Systolic Blood Pressure Measurement Assessment [Baseline to disease progression, averaging one year]
Evaluate systolic blood pressure measurement as assessed by clinically significant abnormal systolic blood pressure measurement changes from baseline
Dose Escalation: Diastolic Blood Pressure Measurement Assessment [Baseline to disease progression, averaging one year]
Evaluate diastolic blood pressure pressure as assessed by the incidence of clinically significant abnormal diastolic blood pressure measurement changes from baseline
Dose Escalation: Respiratory Rate Assessment [Baseline to disease progression, averaging one year]
Evaluate respiratory rate as assessed by by the incidence of clinically significant abnormal respiratory rate changes from baseline
Dose Escalation: Oxygen Level Assessment [Baseline to disease progression, averaging one year]
Evaluate pulse oximetry reading as assessed by by the incidence of clinically significant abnormal oxygen level changes from baseline
Dose Escalation: Body Temperature Assessment [Baseline to disease progression, averaging one year]
Evaluate Body Temperature as assessed by the incidence of clinically significant changes f≥38°C
Dose Escalation: White Blood Cell Count Analysis [Baseline to disease progression, averaging one year]
Evaluate white blood cell count as assessed by the incidence of clinically significant abnormal white blood cell count changes from baseline
Dose Escalation: Serum Absolute Neutrophil Count Analysis [Baseline to disease progression, averaging one year]
Evaluate serum absolute neutrophil as assessed by the incidence of clinically significant abnormal absolute neutrophil count changes from baseline
Dose Escalation: Serum Absolute Lymphocyte Count Analysis [Baseline to disease progression, averaging one year]
Evaluate absolute lymphocyte as assessed by the incidence of clinically significant abnormal absolute lymphocyte count changes from baseline
Dose Escalation: Serum Absolute Monocyte Count Analysis [Baseline to disease progression, averaging one year]
Evaluate serum monocyte count as assessed by the incidence of clinically significant abnormal monocyte count changes from baseline
Dose Escalation: Serum Absolute Eosinophil Count Analysis [Baseline to disease progression averaging one year]
Evaluate absolute eosinophil count as assessed by the incidence of significant abnormal eosinophil count changes from baseline
Dose Escalation: Red Blood Cell Count Analysis [Baseline to disease progression averaging one year]
Evaluate red blood cell count as assessed by the incidence of clinically significant abnormal red blood cell count changes from baseline
Dose Escalation: Blood Hemoglobin Analysis [Baseline to disease progression averaging one year]
Evaluate blood hemoglobin as assessed by the incidence of clinically significant abnormal hemoglobin changes from baseline
Dose Escalation: Blood Platelet Count Analysis [Baseline to disease progression averaging one year]
Evaluate blood platelet count as assessed by the incidence of clinically significant abnormal platelet count changes from baseline
Dose Escalation: International Normalized Ratio Analysis [Baseline to disease progression averaging one year]
Evaluate international normalized ratio as assessed by the incidence of clinically significant abnormal International Normalized Ratio changes from baseline
Dose Escalation: Blood Prothrombin Time Analysis [Baseline to disease progression averaging one year]
Evaluate blood prothrombin time as assessed by the incidence of clinically significant abnormal prothrombin time changes from baseline
Dose Escalation: Blood Activated Partial Thromboplastin Time Analysis [Baseline to disease progression averaging one year]
Evaluate activated partial thromboplastin time as assessed by the incidence of clinically significant abnormal activated partial thromboplastin time changes from baseline
Dose Escalation: Blood Thrombin Time Analysis [Up to Day 15]
Evaluate blood thrombin time as assessed by the incidence of clinically significant abnormal thrombin time changes from baseline
Dose Escalation: Serum Fibrinogen Analysis [Baseline to disease progression averaging one year]
Evaluate serum fibrinogen as assessed by the incidence of clinically significant abnormal fibrinogen changes from baseline
Dose Escalation: Serum Alanine Aminotransferase Analysis [Baseline to disease progression averaging one year]
Evaluate serum alanine aminotransferase as assessed by the incidence of clinically significant abnormal alanine aminotransferase changes from baseline
Dose Escalation: Serum Alkaline Phosphatase Analysis [Baseline to disease progression averaging one year]
Evaluate serum alkaline phosphatase as assessed by the incidence of clinically significant abnormal alkaline phosphatase changes from baseline
Dose Escalation: Serum Aspartate Aminotransferase Analysis [Baseline to disease progression averaging one year]
Evaluate serum aspartate aminotransferase as assessed the incidence of by clinically significant abnormal aspartate aminotransferase changes from baseline
Dose Escalation: Total Blood Urea Nitrogen Analysis [Baseline to disease progression averaging one year]
Evaluate total blood urea nitrogen as assessed by the incidence of clinically significant abnormal total blood urea nitrogen changes from baseline
Dose Escalation: Serum Troponin Analysis [Up to Day 15]
Evaluate serum troponin analysis as assessed by the incidence of clinically significant abnormal troponin changes from baseline
Dose Escalation: Serum Chloride Analysis [Baseline to disease progression averaging one year]
Evaluate serum chloride as assessed by the incidence of clinically significant abnormal chloride changes from baseline
Dose Escalation: Serum Potassium Analysis [Baseline to disease progression averaging one year]
Evaluate serum potassium as assessed by the incidence of clinically significant abnormal potassium changes from baseline
Dose Escalation: Serum Creatinine Analysis [Baseline to disease progression averaging one year]
Evaluate serum creatinine as assessed by the incidence of clinically significant abnormal creatinine changes from baseline
Dose Escalation: Serum Albumin Analysis [Baseline to disease progression averaging one year]
Evaluate serum albumin as assessed by the incidence of clinically significant abnormal albumin changes from baseline
Dose Escalation: Serum Calcium Analysis [Baseline to disease progression averaging one year]
Evaluate serum calcium as assessed by the incidence of clinically significant abnormal calcium changes from baseline
Dose Escalation: Serum Magnesium Analysis [Baseline to disease progression averaging one year]
Evaluate serum magnesium as assessed by the incidence of clinically significant abnormal magnesium changes from baseline
Dose Escalation: Serum Phosphate Analysis [Baseline to disease progression averaging one year]
Evaluate serum phosphate as assessed by the incidence of clinically significant abnormal phosphate changes from baseline
Dose Escalation: Serum Cholesterol Analysis [Baseline to disease progression averaging one year]
Evaluate serum cholesterol as assessed by the incidence of clinically significant abnormal cholesterol changes from baseline
Dose Escalation: Serum Glucose Analysis [Baseline to disease progression averaging one year]
Evaluate serum glucose as assessed by the incidence of clinically significant abnormal glucose changes from baseline
Dose Escalation: Serum Bilirubin Lactate Dehydrogenase Analysis [Baseline to disease progression averaging one year]
Evaluate serum bilirubin as assessed by the incidence of clinically significant abnormal bilirubin lactate dehydrogenase changes from baseline
Dose Escalation: Serum Total Protein Analysis [Baseline to disease progression averaging one year]
Evaluate serum total protein as assessed by the incidence of clinically significant abnormal total protein changes from baseline
Dose Escalation: Serum Triglycerides Analysis [Baseline to disease progression averaging one year]
Evaluate serum triglycerides as assessed by the incidence of clinically significant abnormal triglyceride changes from baseline
Dose Escalation: Serum Uric Acid Analysis [Baseline to disease progression averaging one year]
Evaluate serum uric acid as assessed by the incidence of clinically significant abnormal uric acid changes from baseline
Dose Escalation: Serum Direct Bilirubin Analysis [Baseline to disease progression averaging one year]
Evaluate serum direct bilirubin as assessed by the incidence of clinically significant abnormal direct bilirubin changes from baseline
Dose Escalation: Serum Total Bilirubin Analysis [Baseline to disease progression averaging one year]
Evaluate serum total bilirubin as assessed by the incidence of clinically significant abnormal total bilirubin changes from baseline
Dose Escalation: Urine Bilirubin Analysis [Baseline to disease progression averaging one year]
Evaluate urine bilirubin as assessed by the incidence of clinically significant abnormal urine bilirubin changes from baseline
Dose Escalation: Urine Ketones Analysis [Baseline to disease progression averaging one year]
Evaluate urine ketones as assessed by the incidence of clinically significant abnormal urine ketones changes from baseline
Dose Escalation: Urine pH Analysis [Baseline to disease progression averaging one year]
Evaluate urine pH as assessed by the incidence of clinically significant abnormal urine pH changes from baseline
Dose Escalation: Urine Glucose Analysis [Baseline to disease progression averaging one year]
Evaluate urine glucose as assessed by the incidence of clinically significant abnormal urine glucose changes from baseline
Dose Escalation: Urine Occult Blood Analysis [Baseline to disease progression averaging one year]
Evaluate urine occult blood as assessed by the incidence of clinically significant abnormal urine occult blood changes from baseline
Dose Escalation: Urine Nitrite Analysis [Baseline to disease progression averaging one year]
Evaluate urine nitrite as assessed by clinically significant abnormal urine nitrite changes from baseline
Dose Escalation: Urine Leukocyte Esterase Analysis [Baseline to disease progression averaging one year]
Evaluate urine leukocyte esterase as assessed by the incidence of clinically significant abnormal urine leukocyte esterase changes from baseline
Dose Escalation: Incidence of Urine Protein Analysis [Baseline to disease progression averaging one year]
Evaluate the incidence of urine protein as assessed by the incidence of clinically significant abnormal urine protein changes from baseline
Dose Escalation: Incidence of Urine Specific Gravity Analysis [Baseline to disease progression averaging one year]
Evaluate urine specific gravity as assessed by the incidence of clinically significant abnormal urine specific gravity changes from baseline
Dose Escalation: Incidence of Urine Urobilinogen Analysis [Baseline to disease progression averaging one year]
Evaluate urine urobilinogen as assessed by the incidence of clinically significant abnormal urine urobilinogen changes from baseline
Dose Expansion: Incidence of Abnormal Cardiac Rhythm Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate cardiac rhythm as assessed by the incidence of clinically significant abnormal cardiac rhythm changes from electrocardiogram baseline.
Dose Escalation: Incidence of Abnormal Heart Rate Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate heart rate as assessed by the incidence of clinically significant abnormal heart rate changes from electrocardiogram baseline.
Dose Escalation: Incidence of Abnormal RR Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate RR as assessed by the incidence of clinically significant abnormal RR interval changes from electrocardiogram baseline.
Dose Escalation: Incidence of Abnormal PR Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate PR interval as assessed by the incidence of clinically significant abnormal PR interval changes from electrogram baseline.
Dose Escalation: Incidence of Abnormal QRS Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QRS interval as assessed by the incidence of clinically significant abnormal QRS changes from electrocardiogram baseline
Dose Escalation: Incidence of Abnormal QT Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QT interval as assessed by the incidence of clinically significant abnormal QT interval changes from electrocardiogram baseline
Dose Escalation: Incidence of Abnormal QTcB Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QTcB as assessed by the incidence of clinically significant abnormal QTc changes from electrocardiogram baseline electrocardiogram baseline
Dose Escalation: Incidence of Abnormal QTcF Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QTcF as assessed by the incidence of clinically significant electrocardiogram QTcF interval changes from electrocardiogram baseline
Dose Escalation: Eastern Cooperative Oncology Group Performance Assessment Scale a Standardized Assessment Tool With the Highest Score of 0 is Fully Fully Active and Lowest Score is 4 Dead. [Baseline to disease progression averaging one year]
Evaluate performance as assessed by the incidence of clinically significant abnormal changes from Eastern Cooperative Oncology Group performance scale baseline.
Dose Escalation: : Incidence of Abnormal General Appearance Physical Examination [Baseline to disease progression averaging one year]
Evaluate general appearance as assessed by the incidence of clinically significant abnormal general appearance changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Head Physical Examination [Baseline to disease progression averaging one year]
Evaluate abnormal head as assessed by the incidence of clinically significant abnormal head changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Ear Physical Examination [Baseline to disease progression averaging one year]
Evaluate Ear as assessed by the incidence of clinically significant abnormal ear changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Eye Physical Examination [Baseline to disease progression averaging one year]
Evaluate Eye as assessed by the incidence of clinically significant abnormal eye changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Nose Physical Examination [Baseline to disease progression averaging one year]
Evaluate nose as assessed by the incidence of clinically significant abnormal nose changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Physical Examination Throat [Baseline to disease progression averaging one year]
Evaluate throat as assessed by the incidence of clinically significant abnormal throat changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Thorax (Cardiovascular) Physical Examination [Baseline to disease progression averaging one year]
Evaluate thorax (cardiovascular) as assessed by the incidence of clinically significant abnormal thorax (cardiovascular) changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Thorax (Lung) Physical Examination [Baseline to disease progression averaging one year]
Evaluate thorax (lung) as assessed by the incidence of clinically significant abnormal thorax (Lungs) changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Abdomen Physical Examination [Baseline to disease progression averaging one year]
Evaluate abdomen as assessed by the incidence of clinically significant abnormal abdomen changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Skin Physical Examination [Baseline to disease progression averaging one year]
Evaluate skin as assessed by the incidence of clinically significant abnormal skin changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Musculoskeletal Physical Examination [Baseline to disease progression averaging one year]
Evaluate musculoskeletal as assessed by the incidence of clinically significant abnormal musculoskeletal changes from physical examination baseline
Dose Expansion: Incidence of Abnormal Extremities Physical Examination [Baseline to disease progression averaging one year]
Evaluate extremities as assessed by the incidence of clinically significant abnormal extremity changes from physical examination baseline
Dose Escalation: Incidence of Abnormal Neurological Status Physical Examination [Baseline to disease progression averaging one year]
Evaluate neurological status as assessed by the incidence of clinically significant abnormal neurological changes from physical examination baseline
Dose Escalation : Incidence of Abnormal Cognitive Orientation [Up to Day 60]
Evaluate cognitive orientations as assessed by the incidence of Mini Mental State Examination cognitive orientation score for clinically significant changes from mini mental state examination baseline
Dose Escalation : Incidence of Abnormal Cognitive Attention [Up to Day 60]
Evaluate cognitive attention as assessed by the incidence of clinically significant abnormal significant changes from mini mental state examination cognitive attention baseline
Dose Escalation : Incidence of Abnormal Cognitive Short-Term Recall [Up to Day 60]
Evaluate cognitive short-term recall as assessed by the incidence of clinically significant abnormal changes for Mini Mental State Examination cognitive short-term recall baseline
Dose Escalation: Incidence of Abnormal Cognitive Immediate Recall [Up to Day 60]
Evaluate cognitive immediate recall as assessed by the incidence of clinically significant abnormal changes from Mini Mental State Examination cognitive immediate recall baseline
Dose Escalation :Incidence of Abnormal Cognitive Language [Up to Day 60]
Evaluate cognitive language as assessed by the incidence of clinically significant abnormal changes from Mini Mental State Examination cognitive language baseline
Dose Escalation : Incidence of Abnormal Cognitive Ability to Follow Simple Verbal Commands . [Up to Day 60]
Evaluate ability to follow simple verbal commands as assessed by the incidence of clinically significant abnormal changes from Mini Mental State Examination cognitive ability to follow simple verbal commands baseline
Dose Escalation : Incidence of Abnormal Cognitive Ability to Follow Simple Written Commands . [Up to Day 60]
Evaluate cognitive ability to follow simple written commands as assessed by the incidence of clinically significant abnormal changes from Mini Mental State Examination ability to follow simple written commands baseline
Dose Escalation: TCRT-ESO-A2 Maximum Concentration pharmacokinetic characteristics [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 maximum concentration pharmacokinetic characteristics as assessed by CD3-Positive/Tetramer-Positive T Cells Maximum Concentration
Dose Escalation: TCRT-ESO-A2 Area Under the Plasma Concentration-Time Curve (AUC0-t) pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 area under the curve area under the curve-time plasma concentration -time curve as assessed by CD3-positive/tetramer-positive T Cells Area Under the Plasma Concentration-Time Curve
Dose Escalation: TCRT-ESO-A2 Area Under the Concentration Curve Zero to Infinity (AUC0-∞) pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCR-ESO-A2 area under the concentration curve zero to infinity as assessed by CD3-positive/tetramer-positive T Cells Area Under the Concentration Curve Zero to Infinity
Dose Escalation: Assess TCRT-ESO-A2 Half-Life pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 half-life(t1/2) as assessed by CD3-positive/tetramer-positive T Cells Half-Life
Dose Escalation: TCRT-ESO-A2 time last pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells time last
Dose Escalation: Tumor Response for Complete Response as Assessed by RECIST 1.1. [Day 28 and every 3 months until disease progression averaging one year]
Evaluate tumor response for complete response as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.
Dose Escalation: Tumor Response for Partial Response as Assessed by RECIST 1.1. [Day 28 and every 3 months until disease progression averaging one year]
Evaluate tumor response for partial response response as assessed by RECIST 1.1, standardized assessment with complete response being the highest and disease progression being the lowest outcome.
Dose Escalation: Tumor Response Stable Disease as Assessed by RECIST 1.1. [Day 28 and every 3 months until disease progression averaging one year]
Evaluate tumor response for stable disease response response as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.
Dose Escalation: Tumor Response Disease Progression as Assessed by RECIST 1.1. [Day 28 and every 3 months until disease progression averaging one year]
Evaluate tumor response for disease progression response as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.
Dose Escalation: Tumor Response Overall Survival as Assessed by RECIST 1.1. [Day 28 and every 3 months until disease progression averaging one year]
Evaluate tumor response for overall survival as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.
Dose Escalation: Tumor Response Progression-Free Survival as Assessed by RECIST 1.1. [Day 28 and every 3 months until disease progression averaging one year]
Evaluate tumor response for disease progression-free survival as assessed by RECIST 1.1, a standardized assessment with complete response being the highest and disease progression being the lowest outcome.
Dose Escalation: Persistence of Genetically Modified T Cells in Vivo and T Cell Subpopulations [Day 28 to disease progression averaging one year]
Evaluate the persistence of genetically modified T cells in vivo as assessed by evidence of an abundance of T cell subpopulations in circulation
Dose Escalation: Persistence of Genetically Modified T Cells in Vivo and Antigen Specific CD8 + Cytotoxic T lymphocytes [Day 28 to disease progression averaging one year]
Evaluate persistence of genetically modified T cells in vivo and antigen specific CD8 + cytotoxic T lymphocytes in circulation
Dose Escalation: Phenotype of Genetically Modified T Cells in Vivo and Functional Characteristics [Day 28 to disease progression averaging one year]
Evaluate the phenotype of genetically modified T cells in vivo as assessed by functional characteristics
Dose Escalation: Monitor Presence of Potentially Replication-Competent Lentivirus before TCRT ESO A2 Infusion [Days - 7]
Monitor presence of potentially Replication-Competent Lentivirus before TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein
Dose Escalation: Monitor Presence of Potentially Replication-Competent Lentivirus After TCRT ESO A2 Infusion [Days 90 and 270]
Monitor presence of potentially Replication-Competent Lentivirus after TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein
Maximum Tolerated Dose Expansion: Heart Rate Assessment [Baseline to disease progression averaging one year]
Evaluate heart rate as assessed by the incidence of clinically significant changes from baseline
Maximum Tolerated Dose Expansion: Systolic Blood Pressure Measurement Assessment [Baseline to disease progression averaging one year]
Evaluate systolic blood pressure as assessed by the incidence of systolic blood pressure for clinically significant changes from baseline
Maximum Tolerated Dose Expansion: Diastolic Blood Pressure Measurement Assessment [Baseline to disease progression averaging one year]
Evaluate diastolic blood pressure as assessed by the incidence off clinically significant changes from baseline
Maximum Tolerated Dose Expansion: Respiratory Rate Assessment [Baseline to disease progression averaging one year]
Evaluate respiratory rate as assessed by the incidence of clinically significant changes from baseline
Maximum Tolerated Dose Expansion: Oxygen Level Assessment [Baseline to disease progression averaging one year]
Evaluate pulse oximetry reading as assessed by the incidence of clinically significant oxygen level changes from baseline
Maximum Tolerated Dose Expansion: Body Temperature Assessment [Baseline to disease progression averaging one year]
Evaluate Body Temperature for clinically significant change ≥38°Centergrade from baseline
Maximum Tolerated Dose Expansion: White Blood Cell Count Analysis [Baseline to disease progression averaging one year]
Evaluate white blood cell count as assessed by the incidence of clinically significant abnormal white blood cell count changes from baseline
Maximum Tolerated Dose Expansion: Serum Absolute Neutrophil Count Analysis [Baseline to disease progression averaging one year]
Evaluate serum absolute neutrophil count as assessed by the incidence of clinically significant abnormal absolute neutrophil count changes from baseline
Maximum Tolerated Dose Expansion: Serum Absolute Eosinophil Count Analysis [Baseline to disease progression averaging one year]
Evaluate serum absolute eosinophil count as assessed by the incidence of clinically significant abnormal absolute eosinophil count changes from baseline
Maximum Tolerated Dose Expansion: Serum Absolute Monocyte Count Analysis [Baseline to disease progression averaging one year]
Evaluate serum absolute monocyte count as assessed by the incidence of clinically significant abnormal monocyte count changes from baseline
Maximum Tolerated Dose Expansion: Serum Absolute Lymphocyte Count Analysis [Baseline to disease progression averaging one year]
Evaluate serum absolute lymphocyte count as assessed by the incidence of clinically significant abnormal absolute lymphocyte count cha
Maximum Tolerated Dose Expansion: Serum Alanine Aminotransferase Analysis [Baseline to disease progression averaging one year]
Evaluate clinically significant abnormal alanine aminotransferase (ALT) changes from baseline
Maximum Tolerated Dose Expansion: Serum Aspartate Aminotransferase Analysis [Baseline to disease progression averaging one year]
Evaluate serum aspartate aminotransferase as assessed by the incidence of clinically significant abnormal Aspartate aminotransferase (AST) changes from baseline
Maximum Tolerated Dose Expansion: Serum Creatinine Analysis [Baseline to disease progression averaging one year]
Evaluate serum creatinine as assessed by the incidence of clinically significant abnormal creatinine changes from baseline
Maximum Tolerated Dose Expansion: Red blood cell count Analysis [Baseline to disease progression averaging one year]
Evaluate red blood cell count as assessed by the incidence of clinically significant abnormal red blood cell count changes from baseline
Maximum Tolerated Dose Expansion: Hemoglobin Analysis [Baseline to disease progression averaging one year]
Evaluate hemoglobin as assessed by the incidence of clinically significant abnormal hemoglobin changes from baseline
:Maximum Tolerated Dose Expansion: Blood Activated Partial Thromboplastin Time Analysis [Baseline to disease progression averaging one year]
Significant blood activated partial thromboplastin time as assessed by the incidence of clinically significant abnormal blood activated partial thromboplastin time changes from baseline
Maximum Tolerated Dose Expansion: Blood Activated Partial Thromboplastin Time (aPTT) Analysis [Baseline to disease progression averaging one year]
Significant changes from baseline activated partial thromboplastin time (aPTT) test results
Maximum Tolerated Dose Expansion: Blood Platelet Count Analysis [Baseline to disease progression averaging one year]
Evaluate blood platelet count as assessed by the incidence of clinically significant abnormal Platelet count changes from baseline
Maximum Tolerated Dose Expansion: Serum Fibrinogen Analysis [Baseline to disease progression averaging one year]
Evaluate serum fibrinogen as assessed by the incidence of clinically significant abnormal fibrinogen changes from baseline
:Maximum Tolerated Dose Expansion: Blood Thrombin Time Analysis [Up to Day 15]
Evaluate blood thrombin time as assessed by the incidence of clinically significant abnormal thrombin time changes from baseline
Maximum Tolerated Dose Expansion: Blood Prothrombin Time Analysis [Baseline to disease progression averaging one year]
Evaluate blood prothrombin time as assessed by the incidence of clinically significant abnormal blood prothrombin time changes from baseline
Maximum Tolerated Dose Expansion: Serum Direct Bilirubin Analysis [Baseline to disease progression averaging one year]
Evaluate serum direct bilirubin as assessed by the incidence of clinically significant abnormal direct bilirubin changes from baseline
Maximum Tolerated Dose Expansion: Serum Total Bilirubin Analysis [Baseline to disease progression averaging one year]
Evaluate serum total bilirubin as assessed by the incidence of clinically significant abnormal total bilirubin changes from baseline
Maximum Tolerated Dose Expansion: Total Blood Urea Nitrogen Analysis [Baseline to disease progression averaging one year]
Evaluate total blood urea nitrogen as assessed by the incidence of clinically significant abnormal Total blood urea nitrogen (BUN) changes from baseline
Maximum Tolerated Dose Expansion: Serum Phosphate Analysis [Baseline to disease progression averaging one year]
Evaluate serum phosphate as assessed by the incidence of clinically significant abnormal phosphate changes from baseline
Maximum Tolerated Dose Expansion: Serum Glucose Analysis [Baseline to disease progression averaging one year]
Evaluate serum glucose as assessed by the incidence of clinically significant abnormal glucose changes from baseline
Maximum Tolerated Dose Expansion: Serum Albumin Analysis [Baseline to disease progression averaging one year]
Evaluate serum albumin analysis as assessed by the incidence of clinically significant abnormal albumin changes from baseline
Maximum Tolerated Dose Expansion: Serum Magnesium Analysis [Baseline to disease progression averaging one year]
Evaluate serum magnesium as assessed by the incidence of clinically significant abnormal magnesium changes from baseline
Maximum Tolerated Dose Expansion: Serum Triglycerides Analysis [Baseline to disease progression averaging one year]
Evaluate serum triglycerides as assessed by the incidence of clinically significant abnormal triglyceride changes from baseline
Maximum Tolerated Dose Expansion: Serum Potassium Analysis [Baseline to disease progression averaging one year]
Evaluate serum potassium as assessed by the incidence of clinically significant abnormal potassium changes from baseline
Maximum Tolerated Dose Expansion: Serum Chloride Analysis [Baseline to disease progression averaging one year]
Evaluate serum chloride as assessed by the incidence of clinically significant abnormal chloride changes from baseline
Maximum Tolerated Dose Expansion: Serum Troponin Analysis [Up to Day 15]
Evaluate serum troponin as assessed by the incidence of clinically significant abnormal troponin changes from baseline
Maximum Tolerated Dose Expansion: Serum Calcium Analysis [Baseline to disease progression averaging one year]
Evaluate serum calcium as assessed by the incidence of clinically significant abnormal calcium changes from baseline
Maximum Tolerated Dose Expansion: Serum Cholesterol Analysis [Baseline to disease progression averaging one year]
Evaluate serum cholesterol as assessed by the incidence of clinically significant abnormal cholesterol changes from baseline
Maximum Tolerated Dose Expansion: Serum Alkaline Phosphatase Analysis [Baseline to disease progression averaging one year]
Evaluate serum alkaline phosphatase as assessed by the incidence of clinically significant abnormal alkaline phosphatase changes from baseline
Maximum Tolerated Dose Expansion: International Normalized Ratio Analysis [Baseline to disease progression averaging one year]
Evaluate international normalized ratio as assessed by the incidence of clinically significant abnormal international normalized ratio changes from baseline
Maximum Tolerated Dose Expansion: Serum Total Protein Analysis [Baseline to disease progression averaging one year]
Evaluate serum total protein as assessed by the incidence of clinically significant abnormal total protein changes from baseline
Maximum Tolerated Dose Expansion: Serum Uric Acid Analysis [Baseline to disease progression averaging one year]
Evaluate serum uric as assessed by the incidence of clinically significant abnormal uric acid changes from baseline
Maximum Tolerated Dose Expansion: Serum Bilirubin Lactate Dehydrogenase Analysis [Baseline to disease progression averaging one year]
Evaluate serum bilirubin lactate dehydrogenase as assessed by the incidence of clinically significant abnormal bilirubin lactate dehydrogenase changes from baseline
Maximum Tolerated Dose Expansion: Overall Survival Assessment [Baseline to disease progression averaging one year]
Evaluate overall survival as assessed by RECIST 1.1
Maximum Tolerated Dose Expansion: Objective Response Rate Assessment [3 months]
Evaluate objective response rate as assessed by RECIST 1.1
Maximum Tolerated Dose Expansion: Progression-free Survival Assessment [3 months]
Evaluate progression-free survival 3-months as assessed by RECIST 1.1 every 3 months
Maximum Tolerated Dose Expansion: Disease Control Rate Assessment [3 months]
Evaluate disease control rate at 3-months as assessed by RECIST 1.1
Maximum Tolerated Dose Expansion: Urine Nitrite Analysis [Baseline to disease progression averaging one year]
Evaluate urine nitrite as assessed by the incidence of clinically significant abnormal urine nitrite changes from baseline
Maximum Tolerated Dose Expansion: Urine Protein [Baseline to disease progression averaging one year]
Evaluate urine protein as assessed by the incidence of clinically significant abnormal urine protein changes from baseline
Maximum Tolerated Dose Expansion: Urine Occult Blood Analysis [Baseline to disease progression averaging one year]
Evaluate urine occult blood as assessed by the incidence of clinically significant abnormal urine occult blood changes from baseline
Maximum Tolerated Dose Expansion: Urine Glucose Analysis [Baseline to disease progression averaging one year]
Evaluate urine glucose as assessed by the incidence of clinically significant abnormal urine glucose changes from baseline
Maximum Tolerated Dose Expansion: Urine pH Analysis [Baseline to disease progression averaging one year]
Evaluate urine pH as assessed by the incidence of clinically significant abnormal urine pH blood changes from baseline
Maximum Tolerated Dose Expansion: Urine Ketones Analysis [Baseline to disease progression averaging one year]
Evaluate urine ketones as assessed by the incidence of clinically significant abnormal urine ketones changes from baseline
Maximum Tolerated Dose Expansion: Urine Leukocyte Esterase Analysis [Baseline to disease progression averaging one year]
Evaluate urine leukocyte esterase as assessed by the incidence of clinically significant abnormal urine leukocyte esterase changes from baseline
Maximum Tolerated Dose Expansion: Evaluate Urine Bilirubin Analysis [Baseline to disease progression averaging one year]
Evaluate urine bilirubin as assessed by the incidence of clinically significant abnormal urine bilirubin changes from baseline
Maximum Tolerated Dose Expansion: Urine Specific Gravity Analysis [Baseline to disease progression averaging one year]
Evaluate urine specific gravity as assessed by the incidence of clinically significant abnormal urine specific gravity changes from baseline
Maximum Tolerated Dose Expansion: Urine Urobilinogen Analysis [Baseline to disease progression averaging one year]
Evaluate urine urobilinogen as assessed by the incidence of clinically significant abnormal urine urobilinogen changes from baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Cardiac Rhythm Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate cardiac rhythm as assessed by the incidence of clinically significant abnormal abnormal cardiac rhythm changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Electrocardiogram Heart Rate [Baseline to disease progression averaging one year]
Evaluate heart rate as assessed by the incidence of clinically significant abnormal changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Electrocardiogram RR Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate RR as assessed by the incidence of clinically significant abnormal RR Interval changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal PR Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate PR interval as assessed by the incidence of clinically significant abnormal PR Interval changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal QRS Interval Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QRS as assessed by the incidence of clinically significant changes abnormal QRS interval changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal QT Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QT as assessed by the incidence of clinically significant abnormal QT interval changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal QTcB Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QTc as assessed by the incidence of clinically significant abnormal QTc interval changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal QTcF Electrocardiogram [Baseline to disease progression averaging one year]
Evaluate QTcB as assessed by the incidence of clinically significant abnormal QTcB interval changes from electrocardiogram baseline
Maximum Tolerated Dose Expansion: Use Standardized and Validated Eastern Cooperative Oncology Group Performance Assessment Scale with increasing severity from 0 (Fully Active) to 4 (Dead) to Assess Subject Condition [Baseline to disease progression averaging one year]
Evaluate performance changes as assessed by the incidence of clinically significant performance changes from Eastern Cooperative Oncology Group baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal General Appearance Physical Examination [Baseline to disease progression averaging one year]
Evaluate general appearance as assessed by the incidence of clinically significant abnormal general appearance changes from PE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Head Physical Examination [Baseline to disease progression averaging one year]
Evaluate head as assessed by the incidence of clinically significant abnormal head changes from PE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Ear Physical Examination [Baseline to disease progression averaging one year]
Evaluate ear as assessed by the incidence of clinically significant abnormal ear changes from PE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Eye Physical Examination [Baseline to disease progression averaging one year]
Evaluate eye as assessed by the incidence of clinically significant abnormal eye changes from PE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Nose Physical Examination [Baseline to disease progression averaging one year]
Evaluate nose as assessed by the incidence of clinically significant abnormal nose changes from PE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Throat Physical Examination [Baseline to disease progression averaging one year]
Evaluate throat as assessed by the incidence of clinically significant abnormal throat changes from PE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Thorax (Cardiovascular) Physical Examination [Baseline to disease progression averaging one year]
Evaluate thorax (cardiovascular) as assessed by the incidence of clinically significant abnormal thorax changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Thorax (Lungs) Physical Examination [Baseline to disease progression averaging one year]
Evaluate thorax (lung) as assessed by the incidence of clinically significant abnormal thorax changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Abdomen Physical Examination [Baseline to disease progression averaging one year]
Evaluate abdomen as assessed by the incidence of clinically significant abnormal abdomen changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Clinically Significant Abnormal Musculoskeletal Physical Examination [Baseline to disease progression averaging one year]
Evaluate musculoskeletal as assessed by the incidence of clinically significant abnormal musculoskeletal changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Skin Physical Examination [Baseline to disease progression averaging one year]
Evaluate skin as assessed by the incidence of clinically significant abnormal skin changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Extremities Physical Examination [Baseline to disease progression averaging one year]
Evaluate extremities as assessed by the incidence of clinically significant abnormal extremity changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Neurological Physical Examination [Baseline to disease progression averaging one year]
Evaluate neurological status as assessed by the incidence of clinically significant abnormal neurological changes from physical examination baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Cognitive Orientation as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate cognitive orientation as assessed by the incidence of clinically significant abnormal cognitive orientation changes from Mini Mental State Examination cognitive orientation baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Cognitive Attention as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate cognitive attention as assessed by the incidence of clinically significant abnormal cognitive attention changes from Mini Mental State Examination cognitive attention baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Cognitive Immediate Recall as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate cognitive immediate recall neurological as assessed by the incidence of cognitive immediate recall changes from Mini Mental State Examination cognitive immediate recall baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Cognitive Short-Term Recall as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate cognitive short-term recall as assessed by the incidence of clinically significant abnormal cognitive short-term recall changes from Mental State Examination cognitive short-term recall baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Cognitive Language as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate cognitive language as assessed by the incidence of clinically significant abnormal cognitive language from Mini Mental State Examination cognitive language baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Ability to Follow Simple Verbal Commands as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate ability to follow simple verbal commands as assessed by the incidence of Mental State Examination cognitive ability to follow verbal commands for clinically significant changes from MMSE baseline
Maximum Tolerated Dose Expansion: Incidence of Abnormal Ability to Follow Simple Written Commands as Assessed by the Mini Mental State Examination, a Standardized Assessment Tool with Scoring of 24 to 30 Being Normal and 1 to 17: Being Severe Dementia [Up to Day 60]
Evaluate ability to follow simple written commands as assessed by the incidence of Mini Mental State Examination ability to follow simple written commands .baseline
Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Maximum Concentration Pharmacokinetic Characteristics [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 as assessed by CD3-Positive/Tetramer-Positive T Cells maximum concentration
Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Maximum Concentration pharmacokinetic characteristics [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 as assessed by CD3-Positive/Tetramer-Positive T Cells Time to maximum concentration
Maximum Tolerated Dose Expansion TCRT-ESO-A2 Area Under the Plasma Concentration-Time Curve [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT - ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells Area Under the Plasma Concentration-Time Curve
Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Area Under the Concentration Curve Zero to Infinity pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells Area Under the Concentration Curve Zero to Infinity
Maximum Tolerated Dose Expansion: TCRT-ESO-A2 Half-Life pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells Half-Life
Maximum Tolerated Dose Expansion: TCRT-ESO-A2 time last pharmacokinetic characteristic [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year]
Evaluate TCRT-ESO-A2 as assessed by CD3-positive/tetramer-positive T Cells
Maximum Tolerated Dose Expansion: Evaluate Tumor for Complete Response as Assessed by RECIST 1.1. [Baseline to disease progression averaging one year]
Evaluate tumor for complete response as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment
Maximum Tolerated Dose Expansion: Evaluate Tumor for Partial Response as Assessed by RECIST 1.1. [Baseline to disease progression averaging one year]
Evaluate tumor for partial response as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment
Maximum Tolerated Dose Expansion: Evaluate Tumor for Stable Disease as Assessed by RECIST 1.1. [Baseline to disease progression averaging one year]
Evaluate tumor for stable disease response as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment
Maximum Tolerated Dose Expansion: Evaluate Tumor for Disease Progression as Assessed by RECIST 1.1. [Baseline to disease progression averaging one year]
Evaluate tumor for disease progression as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment
Maximum Tolerated Dose Expansion: Evaluate Tumor for Progression-Free Survival as Assessed by RECIST 1.1. [Baseline to disease progression averaging one year]
Evaluate tumor for progression-free survival as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment
Maximum Tolerated Dose Expansion: Evaluate Tumor for Overall Survival as Assessed by RECIST 1.1. [Baseline to disease progression averaging one year]
Evaluate tumor for overall survival as assessed by RECIST 1.1, a standardized assessment with complete response the highest and disease progression the lowest outcome assessment
Maximum Tolerated Dose Expansion: Persistence of Genetically Modified T Cells in Vivo as Assessed by Functional Characteristics and Persistence in the Circulation [Baseline to disease progression averaging one year]
Evidence of abundance of T cell subpopulations, antigen specific CD8+ cytotoxic T lymphocytes , functional characteristics and persistence in the circulation
Maximum Tolerated Dose Expansion: Monitor Presence of Potentially Replication-Competent Lentivirus (RCL) before TCRT ESO A2 Infusion [Day -7]
Monitor presence of potentially Replication-Competent Lentivirus before TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein
Maximum Tolerated Dose Expansion: Monitor Presence of Potentially Replication-Competent Lentivirus (RCL) after TCRT ESO A2 Infusion [Days 90, 270]
Monitor presence of potentially Replication-Competent Lentivirus after TCRT 001 ESO A2 infusion as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein
Long Term Follow Up Period: Monitor VSV-G DNA qualitative PCR [Progression of disease up to 15 years]
Monitor presence of potentially Replication-Competent Lentivirus as assessed by qualitative PCR assay to detect and measure gene coding copies for the VSV- G Envelope Protein
Long Term Follow Up Period: Monitor New Incidence of Potentially Product-Related Infection [Progression of disease up to 15 years]
Monitor new incidence of potentially product-related infection as assessed by annual or biannual long term follow-up interview
Long Term Follow Up Period: Monitor New Incidence of malignancy [Progression of disease up to 15 years]
Monitor incidence of new malignancy(ies) as reported in annual or biannual long term follow-up interview
Long Term Follow Up Period: Monitor New Incidence or Exacerbation of a Pre-Existing Neurologic Disorder [Progression of disease up to 15 years]
Monitor new incidence or exacerbation of a pre-existing neurologic disorder as reported in annual or biannual long term follow-up interview
Long Term Follow Up Period: Monitor New Incidence or Exacerbation of a Prior Rheumatologic or Other Autoimmune Disorder [Progression of disease up to 15 years]
Monitor new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
Long Term Follow Up Period: Monitor New Incidence of a Hematologic Disorder [Progression of disease up to 15 years]
Monitor new incidence of a hematologic disorder

Other Outcome Measures

Explore Persistence of Genetically Modified T cells in vivo. [Baseline to disease progression averaging one year]
Characteristics of Persistence of Genetically Modified T cells in vivo will be assessed by multiple linear regression.
Explore Phenotype of Genetically Modified T cells in vivo. [Baseline to disease progression averaging one year]
Characteristics of phenotype of genetically modified T cells in vivo will be assessed by multiple linear regression.
Explore Presence of CA-125 Tumor Immune Biomarker Before TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of CA-125 tumor biomarker before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Presence of CA-125 Tumor Immune Biomarker after TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of CA-125 Tumor Biomarker After TCRT-ESO-A2 Infusion will be assessed by multiple linear regression.
Explore Presence of CEA Tumor Immune Biomarker Before TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of CEA tumor immune biomarker before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Presence of CEA Tumor Immune Biomarker After TCRT-ESO-A2 infusion [Baseline to disease progression averaging one year]
The presence of CEA tumor immune biomarker after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Presence of PSA Tumor Immune Biomarker Before TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of PSA tumor biomarker before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Presence of PSA Tumor Immune Biomarker After TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of PSA tumor biomarker after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Distribution of PSA Tumor immune Biomarker After TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The distribution of PSA tumor biomarker after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Cytokine IFN-γ Presence Before TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of systemic cytokine IFN-γ before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Cytokine IFN-γ Presence After TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of systemic cytokine IFN-γ after TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Presence of Targeted Antigen NY-ESO-1, Before TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
The presence of targeted antigen NY-ESO-1 before TCRT-ESO-A2 infusion Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months will be assessed by multiple linear regression.
Explore Presence of Targeted Antigen NY-ESO-1 After TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
Evaluate the presence and distribution of and targeted antigen NY-ESO-1 after TCRT-ESO-A2 infusion
Explore Distribution of Targeted Antigen NY-ESO-1 After TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
Evaluate the distribution of targeted antigen NY-ESO-1 after before TCRT-ESO-A2 infusion will be assessed by multiple linear regression.
Explore Presence of PSA Tumor Immune Biomarker [Baseline to disease progression averaging one year]
The presence of PSA tumor biomarker will be assessed by multiple linear regression.
Explore Presence of CEA Tumor Immune Biomarker [Baseline to disease progression averaging one year]
The presence of CEA tumor biomarker will be assessed by multiple linear regression.
:Explore Persistence of Genetically Modified T cells in vivo. [Baseline to disease progression averaging one year]
Characteristics of persistence of genetically modified T cells in vivo will be assessed by multiple linear regression.
Explore Evaluate Presence of Cytokine IFN-γ MTD Expansion: Evaluate cytokine IFN-γ before and after TCRT-ESO-A2 infusion [Baseline to disease progression averaging one year]
The presence of systemic cytokine IFN-y will be assessed by multiple linear regression
Explore Evaluate Cytokine IFN-γ Before TCRT-ESO-A2 Infusion MTD Expansion: Evaluate cytokine IFN-γ before and after TCRT-ESO-A2 infusion [Baseline to disease progression averaging one year]
Evaluate the presence of systemic cytokine IFN-y before TCRT-ESO-A2 infusion will be assessed by multiple linear regression
Explore Presence of Targeted Antigen NY-ESO-1 Before TCRT-ESO-A2 Infusion [Baseline to disease progression averaging one year]
Evaluate the presence of targeted antigen NY-ESO-1, before TCRT-ESO-A2 infusion will be assessed by multiple linear regression
Explore Perform NY-ESO-1 Immunohistochemistry Assay Using a Four-point Semi-quantitative Scale (low to high): 0, 1+, 2+, 3+ With High Inferring a Better Outcome [Baseline to disease progression averaging one year]
Evaluate the subject tumor to determine cut-off high and low NY ESO - 1 expression.
Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine IFN-γ Level [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
The association between maximum TCRT ESO A2 concentration time and systemic cytokine IFN-γ level will be assessed by multiple linear regression.
Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine IL-6 Level [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
The association between maximum TCRT ESO A2 concentration time and systemic cytokine IL-6 level will be assessed by multiple linear regression.
Explore Association Between Maximum TCRT ESO A2 Concentration time and Systemic Cytokine TNFα Level [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
The association between maximum TCRT ESO A2 concentration time and systemic cytokine IFN-γ level will be assessed by multiple linear regression.
Explore Association Between Maximum Dose Concentration Time and Disease Appropriate Circulating Tumor Marker CA-125 [Day 28]
The association between pharmacokinetic maximum dose concentration time and pharmacodynamic disease appropriate circulating tumor marker CA-125 will be assessed by multiple linear regression.
Explore Association Between Pharmacokinetic Maximum Dose Concentration Time and Disease Appropriate Circulating Tumor Marker CEA [Day 28]
The association between pharmacokinetic maximum dose concentration time and pharmacodynamic disease appropriate circulating tumor marker CEA will be assessed by multiple linear regression.
Explore Association Between Pharmacokinetic Maximum Dose Concentration and disease Appropriate Circulating Tumor Marker PSA [Day 28]
The association between pharmacokinetic maximum dose concentration time and pharmacodynamic circulating tumor marker PSA will be assessed by multiple linear regression.
Explore Association Between Pharmacokinetic Maximum TCRT ESO A2 Dose Concentration Time and Pharmacodynamic Adverse Events as Identified by CTCAE Version 5. [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
The association between pharmacokinetic parameters and pharmacodynamic adverse event incidence will be assessed by rank correlation.
Explore Association Between Pharmacokinetic Maximum Dose Concentration time and Pharmacodynamic Adverse Event Incidence. [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
Explore association between pharmacokinetic maximum dose concentration time and pharmacodynamic adverse event incidence.
Explore Association Between Pharmacokinetic Maximum Dose Concentration and Area Under the Curve zero to infinity [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
The association between maximum tolerated dose and area under the curve zero to infinity will be assessed by multiple linear regression.
Explore Pharmacokinetic Relationship with Tlast of CD3-positive/tetramer-positive T cells [Day -7, 1,2,3, 4, 5, 8,15, 28, 60, 90, 180, 270 and every 3 months until disease progression averaging one year.]
The association between pharmacokinetic parameters and [variable] will be assessed by multiple linear regression.
Explore Pharmacokinetic Relationship with Phenotype of Genetically Modified T cells in vivo [Baseline to disease progression averaging one year]
The association between pharmacokinetic parameters and phenotype of genetically modified T cells in vivo will be assessed by multiple linear regression.
Explore Pharmacokinetic Relationship with Tumor Objective Response Rate by RECIST 1.1 [3 months]
The association between pharmacokinetic parameters and objective response rate will be assessed by multiple linear regression.
Explore Pharmacokinetic Relationship with Progression-Free Survival by RECIST 1.1 [3 months]
The association between pharmacokinetic parameters and progression-free survival will be assessed by multiple linear regression.
Explore Pharmacokinetic Relationship With Disease Control Rate RECIST 1.1 [3-months]
The association between pharmacokinetic parameters and disease control rate will be assessed by multiple linear regression
Explore Pharmacokinetic Relationship With Overall Survival RECIST 1.1 [Baseline to disease progression averaging one year]
The association between pharmacokinetic parameters and overall survival will be assessed by multiple linear regression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Able to understand and voluntarily sign an informed consent form (ICF).
Age ≥18 years of age at the time of informed consent.
HLA-A*0201 positive by high resolution testing.
Any of the following solid tumors with positive NY-ESO-1 expression characterized by

IHC:

Head and neck cancer with ≥85% of tumor cells scored ≥1+.
Hepatocellular carcinoma with ≥20% of tumor cells scored ≥1+.
Lung squamous cell carcinoma with ≥20% of tumor cells scored ≥1+.
Synovial sarcoma with ≥65% of cells scored ≥1+.
Triple-negative breast cancer with ≥20% of cells scored ≥1+.
Received standard curative or palliative therapy including any targeted therapy based on mutation status for their cancer, or advanced solid tumors for which there is no accepted therapy, standard therapies are no longer effective, or the subject refuses additional standard therapy.
Measurable disease as defined per RECIST 1.1 (Eisenhauer 2009).
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
Life expectancy of >4 months.
Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
White blood cell count ≥3,000/mcL.
Absolute neutrophil count ≥1,000/mcL.
Platelet count ≥100,000/mcL.
Hemoglobin ≥9.0 g/dL.
Adequate liver function as demonstrated by:
Serum alanine transaminase (ALT) and aspartate transaminase (AST) ≤3 × upper limit of normal, except in subjects with liver metastasis, who must have AST and ALT ≤5 × upper limit of normal.
Total bilirubin ≤1.5 × upper limit of normal, except in subjects with Gilbert's Syndrome, who must have total bilirubin ≤3.0 × upper limit of normal.
Creatinine clearance ≥50 mL/min. Creatinine clearance of subjects <65 years of age may be estimated by the Cockcroft-Gault formula. Subjects ≥65 years of age must have renal function measured either by 24-hour urine creatinine collection or by nuclear medicine glomerular filtration rate.
Prior therapies:
Targeted or immunotherapy must be completed at least 4 weeks prior to leukapheresis.
Chemotherapy must be completed at least 3 weeks prior to leukapheresis.
Systemic corticosteroid or other immunosuppressive therapy must be completed at least 2 weeks prior to leukapheresis.
Recovered from previous surgery or treatment-related adverse reactions to <grade 2 CTCAE (except for toxicities such as alopecia or vitiligo or toxicities that may be permanent such as neuropathy) prior to lymphodepletion chemotherapy.
Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a condom with spermicide and to not donate sperm during the study and until the persistence of TCRT-ESO-A2 is no longer detected by qPCR or up to 15 years.
Women of non-child bearing potential due to surgical sterilization (at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history or menopause (i.e., no menstrual bleeding for more than 12 months in a woman aged ≥45 years), OR women of childbearing potential who test negative for pregnancy at Screening based on serum pregnancy test must be using a highly effective method of contraception from the time of Screening until the persistence of TCRT-ESO-A2 is no longer detected by qPCR or up to 15 years. Note: Highly effective methods of contraception that result in a low failure rate (i.e., <1% per year) when used consistently and correctly include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. True abstinence, when in line with the preferred and usual lifestyle of the subject, is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of study participation and until the persistence of TCRT-ESO-A2 is no longer detected by qPCR. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and post-ovulation method) and withdrawal are not acceptable methods of contraception.

5.3 Exclusion Criteria

Eligible subjects must not have/be:

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
Known allergic reactions to any component of the treatments in this study.
Echocardiography (ECHO) or multigated acquisition scan (MUGA) indicative of left ventricular ejection fraction (LVEF) ≤45%.

Exclusion Criteria:

Eligible subjects must not have/be:

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease or AIDS).
Known allergic reactions to any component of the treatments in this study.
Echocardiography (ECHO) or multigated acquisition scan (MUGA) indicative of left ventricular ejection fraction (LVEF) ≤45%.
Pulmonary function test of forced expiratory volume in the first second (FEV1) ≤60% in subjects with a prolonged history of cigarette smoking (e.g. ≥20 pack-year smoking history).
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
Subjects with infection requiring treatment, including but not limited to active tuberculosis, COVID-19, known HIV positive subjects or subjects with clinically active hepatitis A, B and C.
Planning to take the following medications within 4 weeks of TCRT-ESO-A2 infusion or during the study: long-term systemic use of steroid hormones, hydroxyurea, immunomodulatory drugs (such as interleukin 2, interferon α or γ, GM-CSF, mTOR inhibitor, cystatin, thymosin, etc.). Recent use of inhaled or topical steroids, topical 5-fluorouracil is not exclusionary, however, use of inhaled steroids before leukapheresis and blood draws should be discouraged.
Untreated or symptomatic brain metastasis.
History of organ transplantation or allogeneic stem cell transplantation.
Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure.
Previous use of any gene therapy product.
Not suitable for enrollment at the discretion of the Principal Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor University Medical Cancer Hospital	Dallas	Texas	United States	75246

Sponsors and Collaborators

Athenex, Inc.

Investigators

Principal Investigator: Carlos Becerra, MD, Baylor University Medical Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Athenex, Inc.

ClinicalTrials.gov Identifier:

NCT04878484

Other Study ID Numbers:

AX TCRT 001

First Posted:

May 7, 2021

Last Update Posted:

Feb 3, 2022

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Athenex, Inc.

NY-ESO-1

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Feb 3, 2022