RecruitingPhase 1NCT06473961

A Phase Ib Study of GC101 in NSCLC

An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer


Sponsor

Shanghai Juncell Therapeutics

Enrollment

20 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

20 participants are expected to be enrolled for the Phase Ib clinical trial,this trail is expected to be finished in 36 months.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called GC101 — a treatment that uses a patient's own immune cells (called TILs, or tumor-infiltrating lymphocytes) that are collected from a tumor, grown in large numbers in a lab, and then put back into the body to fight the cancer. It is being tested in people with advanced non-small cell lung cancer that has stopped responding to targeted therapy and chemotherapy. **You may be eligible if...** - You are between 18 and 70 years old - You have advanced non-small cell lung cancer that has not responded to targeted therapy and platinum-based chemotherapy - Your tumor is accessible for biopsy or minor surgery to collect immune cells - You still have at least one measurable area of cancer remaining after the tissue collection - You are generally in good health and able to carry out daily activities **You may NOT be eligible if...** - You have received more than 5 prior lines of cancer treatment - You have active autoimmune disease requiring immune-suppressing drugs - You have had an organ transplant - You have HIV, active Hepatitis B or C, or active tuberculosis - You are pregnant or breastfeeding - You have severe heart or lung problems 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

BIOLOGICALAutologous Tumor Infiltrating Lymphocytes

A tumor sample is resected from each participant and cultured ex vivo to generate tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC101 TIL followed low-dose PD-1 antibody.


Locations(1)

Shanghai Chest Hospital

Shanghai, China

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NCT06473961


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