What is GC203 TIL studying for pancreatic ductal adenocarcinoma?

GC203 TIL is being studied as a gene-edited immune cell therapy for pancreatic ductal adenocarcinoma. Researchers want to evaluate its safety and how well it works in patients who have not responded to standard treatments. The study is sponsored by Shanghai Juncell Therapeutics.

Who may be eligible for this pancreatic ductal adenocarcinoma clinical trial?

Adults aged 18 to 70 years with a diagnosis of pancreatic ductal adenocarcinoma who have undergone tumor resection for gene-edited GC203 TIL production may be eligible. Participants should have an expected life-span over 3 months and an ECOG score of 0 or 1. Please review eligibility criteria for more details.

Is there any cost to participate in this pancreatic ductal adenocarcinoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Early Phase 1

Age: 18Years - 70Years

All Genders

ID06828328

Phase I Study of Gene-Edited GC203 Tumor Infiltrating Lymphocyte Therapy for Pancreatic Ductal Adenocarcinoma

Led by Shanghai Juncell Therapeutics · Updated on 2026-08-05

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a gene-edited tumor infiltrating lymphocyte therapy called GC203 TIL in patients with pancreatic ductal adenocarcinoma. This early-phase study involves patients who have undergone tumor resection to produce the gene-edited TILs and have failed standard treatment options. The study aims to better understand how this therapy may work in this patient population. Participants receive an infusion of GC203 TILs, which are expanded from their tumor tissue, after receiving a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine 600 mg and cyclophosphamide. The infused dose ranges from 5x108 to 1.5x1010 cells with a 20% variability. The treatment is given intravenously following the preparative lymphodepletion regimen. Throughout the study, participants are closely monitored for adverse events over six months and evaluated for tumor responses, disease control, duration of response, progression-free survival, and overall survival for up to 36 months. Follow-up includes regular assessments to track treatment effects and safety. The total participation period spans several years to capture both immediate and long-term outcomes of the therapy.

CONDITIONS

Brief Title

A Study of GC203 TIL in PDCA (RJ)

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Have undergone tumor resection for gene-edited GC203 TIL production and successfully produced the cells
Age between 18 and 70 years
Histologically diagnosed with pancreatic ductal adenocarcinoma
Expected life-span longer than 3 months
ECOG performance score of 0 or 1
Have failed standard treatment regimens and willing to receive gene-edited GC203 TIL therapy
Have at least one evaluable tumor lesion
Meet hematology and chemistry requirements within 7 days prior to enrollment, including specific blood counts and organ function tests
Willing to practice approved highly effective contraception during consent and for 1 year after lymphodepletion treatment if of child-bearing potential
Ceased any malignant tumor-targeting therapies at least 28 days before obtaining TILs
Able to understand and sign informed consent
Able to follow-up and comply with study requirements

You will not qualify if you...

Have other malignant tumors except those cured or inactive for 5 years with low risk of recurrence
Need glucocorticoid treatment with prednisone over 10 mg daily or have autoimmune diseases requiring immunomodulatory treatment
Have oxygen saturation below 95% at rest
Have active infections such as HIV, HBV, HCV, syphilis
Have significant cardiovascular diseases including severe heart failure or arrhythmias
Have uncontrolled metabolic or systemic diseases increasing medical risk
Have esophageal or gastric varices needing immediate intervention or portal hypertension
Have severe liver diseases like hepatic encephalopathy or liver failure
Have pulmonary fibrosis, interstitial lung disease, or acute lung disease
Have uncontrollable third space effusions like pleural fluid or ascites
Have untreated or uncontrolled central nervous system metastases
Have severe physical or mental diseases
Have active systemic infections requiring treatment
Have received other cancer treatments within the past month
History of allogeneic T cell therapy
Have had severe immune-related adverse events from immunotherapy
Have unresolved previous anti-tumor treatment adverse events above grade 1
Are pregnant or breastfeeding
History of organ or stem cell transplantation or renal replacement therapy
Considered unsuitable by researchers due to other severe diseases or reasons

Research Team

boyong shen

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Phase I Study of Gene-Edited GC203 Tumor Infiltrating Lymphocyte Therapy for Pancreatic Ductal Adenocarcinoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria