RecruitingEarly Phase 1NCT05098197

A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)

A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Hepatobiliary-Pancreatic Cancers


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 hepatobiliary-pancreatic cancers. 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 tumor-infiltrating lymphocyte (TIL) cell therapy — immune cells grown from your own tumor — for people with advanced liver, bile duct, or pancreatic cancers that have stopped responding to standard treatments. **You may be eligible if...** - You have been diagnosed with liver (hepatocellular), bile duct (hepatobiliary), or pancreatic cancer confirmed by biopsy - You are between 18 and 75 years old - You have already tried standard treatments without success, or no standard options are available - You have at least one tumor that can be biopsied or removed to harvest immune cells - Your blood counts and organ function meet the required levels - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have severe organ failure or serious active infections - You are pregnant or breastfeeding - You have no tumor tissue accessible for harvesting TIL cells - Your blood counts are too low to safely proceed 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, Shanghai Municipality, China

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NCT05098197


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