RecruitingEarly Phase 1NCT06828328

A Study of GC203 TIL in PDCA (RJ)

A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Pancreatic Ductal Adenocarcinoma


Sponsor

Shanghai Juncell Therapeutics

Enrollment

10 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to investigate the safety and efficacy of gene-edited tumor infiltrating lymphocyte (GC203 TIL) therapy in patients with pancreatic ductal adenocarcinoma. Gene-edited 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: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer immunotherapy called GC203 TIL — immune cells (tumor-infiltrating lymphocytes) taken from a patient's own tumor, genetically modified, and then infused back — for people with pancreatic ductal adenocarcinoma (a common and aggressive type of pancreatic cancer) that has not responded to standard treatments. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of pancreatic ductal adenocarcinoma - You have already undergone tumor removal surgery so the modified immune cells can be manufactured - Your cancer has failed standard treatment regimens - You have at least one measurable tumor remaining - Your blood cell counts and organ function meet minimum thresholds - Your expected survival is at least 3 months - You are in good physical condition (ECOG score 0–1) **You may NOT be eligible if...** - You have not had tumor resection surgery (required to produce the cell therapy) - You have serious infections or significant organ failure - You have active autoimmune disease - 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

BIOLOGICALGC203 TIL

the candidates will be assigned to GC203 TIL(gene-edited TIL) group


Locations(1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT06828328


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