Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Sponsor

AbClon (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05338931

Collaborator

(none)

Enrollment

Location

Arm

102

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.

Condition or Disease	Intervention/Treatment	Phase
B-cell Non Hodgkin Lymphoma	Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)	Phase 1/Phase 2

Detailed Description

Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-Hodgkin lymphoma (B-cell NHL).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Single-arm, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of AT101 (Anti-CD19 Chimeric Antigen Receptor T Cell) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2030

Anticipated Study Completion Date :

Sep 15, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AT101(Anti-CD19 Chimeric Antigen Receptor T cell) Anti-CD19 Chimeric Antigen Receptor T cell	Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell) Anti-CD19 Chimeric Antigen Receptor T cell Other Names: AT101

Arm

Intervention/Treatment

Experimental: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Anti-CD19 Chimeric Antigen Receptor T cell

Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

Anti-CD19 Chimeric Antigen Receptor T cell

Other Names:

AT101

Outcome Measures

Primary Outcome Measures

Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) [28 days]
Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials
Overall response rate (ORR) by Independent assessment [5 years]
Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response

Secondary Outcome Measures

Overall response rate (ORR) by Investigator assessment [5 years]
Proportion of subjects whose best overall response in tumor evaluation
Duration of overall response (DOR) [5 years]
Time from first response (CR or PR) to the date of initial objectively documented progression
Overall survival(OS) [5 years]
Time from randomization to death
Progression free survival (PFS) [5 years]
Time from randomization to disease progression or death
Time to response (TTR) [5 years]
Time from randomization to CR or PR
Event free survival (EFS) [5 years]
Time from randomization to progression, subsequent chemotherapy or death
Incidence of adverse Event [5 years]
Peak concentration (Cmax) of AT101 [5 years]
Area under the concentration versus time curve (AUC) of AT101 [5 years]
AT101 transgene expression [5 years]
Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase [5 years]

Other Outcome Measures

Concentration of cytokines [5 years]
CD19 expression [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

B cell non-Hodgkin lymphoma based on WHO classification 2017
incompatible with existing standard therapies or have had disease progression, and whose standard therapies do not currently have available standard therapies due to reasons such as intolerance/inadequacies or rejection
The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening
Those with a minimum life expectancy of 12 weeks or more
In women with childbearing, clinical response tests (serum- or ure-hCG) were negatively identified during this trial
Those who have agreed in writing to participate voluntarily in this trial

Exclusion Criteria:

Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
At101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
Those who cannot take autologous blood
Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
Persons who have not been recovered (CTCAE grade ≤1 or baseline) due to previous treatment
Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
Those who have identified the following forces at the time of screening:

Those who have been clinically aware of heart disease within 6 months prior to screening
Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening
Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening
Those who have undergone major surgery within 4 weeks prior to screening
Those who have undergone non-critical surgery within two weeks prior to screening

Childbearing women or men who do not have the will to use effective contraception for a longer period of time, either 12 months after clinical trial period and AT101 administration or when AT101 in the body is not identified
Those who have been administered or applied to other IP/ID within 4 weeks of screening
Those who are addicted to alcohol and/or medication
Those who are unfit or unable to participate in this trial when judged by PI