RecruitingEarly Phase 1NCT04943913

Study of GC101 TIL in Brain Glioma (Soochow2)

A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Brain Glioma


Sponsor

Shanghai Juncell Therapeutics

Enrollment

50 participants

Start Date

May 6, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment using the patient's own tumor-infiltrating lymphocytes (TIL) — immune cells extracted from the tumor, grown in large numbers in a lab, and then infused back into the patient — for people with brain glioma (a type of brain tumor) that has not responded to standard treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with primary, relapsed, or metastatic brain glioma confirmed by biopsy - Your expected survival is more than 3 months - Standard treatments have failed or are not available for you - You have a tumor site accessible for biopsy or surgical removal to collect immune cells - You are in reasonably good health (ECOG 0-2 or Karnofsky ≥60) **You may NOT be eligible if...** - You have not failed standard treatments (if they are available) - No tumor site is accessible for immune cell collection - Your blood counts or organ function are below minimum thresholds - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor Infiltrating Lymphocytes (TIL)

Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.


Locations(1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT04943913


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