RecruitingEarly Phase 1NCT05098184

A Study of GC101 TIL in Advanced Melanoma (10hospital)

A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Melanoma


Sponsor

Shanghai Juncell Therapeutics

Enrollment

50 participants

Start Date

Sep 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies 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 is testing a special type of cancer-fighting immune cell therapy called TIL (tumor-infiltrating lymphocytes) — cells taken from your own tumor, grown in a lab, and put back into your body to fight advanced melanoma (a type of skin cancer). **You may be eligible if...** - You have been diagnosed with melanoma (primary, relapsed, or metastatic) confirmed by biopsy - You are between 18 and 75 years old - You are reasonably active and able to care for yourself - Standard treatments have not worked or are not available for you - You have tumor tissue that can be biopsied or removed to grow the TIL cells - Your blood counts and organ function meet required minimums - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have severe heart, lung, or kidney disease - You are pregnant or breastfeeding - You have an active serious infection - You are unable to meet the blood count or organ function requirements 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 Lymphocyte

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


Locations(1)

Shanghai Tenth People's Hospital

Shanghai, China

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NCT05098184


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