Study on TIL for the Treatment of Brain Glioma

Early Phase 1

Recruiting

• Conditions: Glioma
• Interventions: Biological: Tumor Infiltrating Lymphocytes (TIL)

• Registration Number: NCT04943913
• Lead Sponsor: Shanghai Juncell Therapeutics

Brief Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-06
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2024-12-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
5. Severe physical or mental diseases;
6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection);
7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
9. Having received immunotherapy and developed irAE level greater than Level 3;
10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
11. Females in pregnancy or lactation;
12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy;
13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor Infiltrating Lymphocytes	Tumor Infiltrating Lymphocytes (TIL)	1x10\^9-5x10\^10 in vitro expanded autologous TILs will be infused i.v. to patients with brain glioma after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR）	Up to 36 months	Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1
Progression-Free Survival (PFS)	Up to 36 months	The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Overall Survival (OS)	Up to 36 months	The length of time from the date of the start of TIL treatment that the patients are still alive
Adverse Events (AE)	1 month	To characterize the safety profile of GC101 TIL in patients with advanced brain glioma as assessed by incidence of adverse events.
Objective Response Rate (ORR)	Up to 36 months	Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD.; ( Except baseline evaluation within 28 days before GC101 TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
Duration of Response (DOR)	Up to 36 months	The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Partial Response (PR)	Up to 36 months	Percentage of patients with partial response per RECIST 1.1 to TIL treatment
Change in Quality of Life	Up to 36 months	Comparison of patients' quality of life before and after TIL treatment as assessed by the EORTC QLQ-30 (V3.0).
Stable Disease (SD)	Up to 36 months	Patients with stable disease per RECIST 1.1 to TIL treatment
Progressive Disease (PD)	Up to 36 months	Patients with progressive disease per RECIST 1.1 to TIL treatment
Complete Response(CR)	Up to 36 months	Patients with complete response per RECIST 1.1 to TIL treatment

Trial Locations

Locations (1)

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China