Actively Recruiting
A Study of GC203 TIL in PDCA (RJ)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-23
10
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of GC203 TIL in PDCA (RJ)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have had tumor resection for gene-edited GC203 TIL production and successfully produced cells
- Age between 18 and 70 years
- Diagnosed histologically with pancreatic ductal adenocarcinoma
- Expected life span of more than 3 months
- ECOG performance status score of 0 or 1
- Have failed standard treatment regimens and are willing to receive gene-edited GC203 TIL therapy
- At least one evaluable tumor lesion
- Hematology and chemistry labs within 7 days before enrollment meeting specified limits: white blood cells ≥2.5x10^9/L; neutrophils ≥1.5x10^9/L; lymphocytes ≥0.7x10^9/L; platelets ≥90x10^9/L; hemoglobin ≥90 g/L; APTT ≤1.5xULN (unless anticoagulant therapy within 3 days); INR ≤1.5xULN (unless anticoagulant therapy within 3 days); serum creatinine ≤1.5 mg/dL or clearance rate ≥50 mL/min; ALT/AST ≤3xULN (for liver metastasis patients ≤3xULN); total bilirubin ≤1.5xULN
- Subjects with child-bearing potential must agree to use highly effective contraception during consent and for 1 year after lymphodepletion
- All malignant tumor-targeting therapies must have stopped at least 28 days before obtaining TILs
- Able to understand and sign informed consent
- Able to comply with follow-up visits and study requirements
You will not qualify if you...
- Presence of other malignant tumors except cured and inactive for at least 5 years with low recurrence risk; non-melanoma skin cancer or malignant lentigo adequately treated with no recurrence; carcinoma in situ adequately treated with no recurrence
- Need for glucocorticoid treatment with prednisone dose >10 mg daily or equivalent, or autoimmune diseases requiring immunomodulatory treatment
- Oxygen saturation below 95% at rest
- HIV infection or positive anti-HIV antibody, active hepatitis B or C infection, syphilis infection or positive Treponema pallidum antibody
- Significant cardiovascular diseases including NYHA class III or IV heart failure, clinically significant low blood pressure, uncontrolled coronary artery disease, ejection fraction <35%, severe arrhythmias requiring intervention, or advanced heart conduction blocks
- Uncontrolled metabolic disorders like diabetes or other non-malignant systemic diseases increasing medical risk
- Esophageal or gastric varices needing immediate intervention or evidence of portal hypertension or history of variceal bleeding without endoscopic evaluation within 3 months
- Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh grade B or worse cirrhosis, or liver failure
- Pulmonary fibrosis, interstitial lung disease, or acute lung disease
- Uncontrolled third space fluid accumulation such as pleural effusion or ascites
- Known or uncontrolled central nervous system metastases except stable treated cases off glucocorticoids and anticonvulsants for at least 4 weeks
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Treatment with other medications, biologics, chemotherapy, or radiotherapy within past month or ongoing
- History of allogeneic T cell therapy
- Immunotherapy with immune-related adverse events above grade 3
- Previous anti-tumor treatment adverse events not resolved to grade 1 or lower except non-safety concerns like hair loss
- Pregnant or breastfeeding females
- History of organ transplantation, allogeneic stem cell transplant, or renal replacement therapy
- Other severe systemic diseases or reasons inappropriate for clinical study as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
B
boyong shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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