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TIL Cells for the Treatment of the Advanced Solid Tumors Patients

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05649618
Collaborator
(none)
42
Enrollment
1
Arm
38.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

This is a single-center, open-label, Phase I clinical study of TILs for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TILs in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy
Anticipated Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tumor Infiltrating Lymphocytes

TIL cells (2.5×10^9-5×10^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.

Biological: Tumor Infiltrating Lymphocytes
On day 0 patients will be intravenous infusion of TILs

Drug: Fludarabine
Part of the non-myeloablative lymphocyte-depleting preparative regimen

Drug: Cyclophosphamide Capsules
Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Drug: IL-2
Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

Outcome Measures

Primary Outcome Measures

  1. Dose Limiting Toxicity [up to Day 28]

    Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TILs therapy.

  2. Adverse Event [up to 24 months]

    The severity and incidence of various adverse events and serious adverse events

Secondary Outcome Measures

  1. Overall response rate(ORR) [up to 24 months]

  2. Progression free survival (PFS) [up to 24 months]

  3. Overall survival (OS) [up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;

  2. 18 ~ 75 years;

  3. The expected survival period is at least 3 months;

  4. ECOG score of 0-1;

  5. There is at least one lesion that can be operated or biopsied for the preparation of TIL;

  6. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;

  7. Patients with recurrent or metastatic solid tumors confirmed by histopathology;

  8. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression

Exclusion Criteria:

  1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ;

  2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;

  3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;

  4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;

  5. Patients who have received adoptive cell therapy in the past;

  6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fujian Cancer Hospital

Investigators

  • Principal Investigator: zhiyong He, Fujian Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05649618
Other Study ID Numbers:
  • FJ001
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms
Cyclophosphamide
Fludarabine

Study Results

No Results Posted as of Dec 14, 2022