Actively Recruiting
A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Pancreatic Ductal Adenocarcinoma
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of a gene-edited tumor infiltrating lymphocyte therapy called GC203 TIL for patients with pancreatic ductal adenocarcinoma. This early-phase study focuses on patients who have undergone tumor resection and have failed standard treatments, aiming to evaluate how this treatment works in this serious form of pancreatic cancer. Participants will receive an infusion of expanded gene-edited GC203 TILs, ranging from 5x10^8 to 1.5x10^10 cells, following a non-myeloablative lymphodepletion treatment that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The infusion is given intravenously after the lymphodepletion process. The study monitors patients for adverse events over six months and tracks various measures of tumor response and survival up to 36 months. Throughout the study, participants will undergo evaluations including blood tests and tumor assessments to monitor safety and treatment effects. Researchers will examine adverse events and tumor response rates, as well as progression-free and overall survival. Participants are expected to follow scheduled visits and assessments, with continuous monitoring for safety and treatment outcomes during the study period.
CONDITIONS
Brief Title
A Study of GC203 TIL in PDCA (RJ)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have undergone tumor resection for gene-edited GC203 TIL production and successfully produced it
- Age between 18 and 70 years
- Histologically diagnosed with pancreatic ductal adenocarcinoma
- Expected life-span more than 3 months
- ECOG performance score of 0 or 1
- Failed standard treatment regimens and willing to receive gene-edited GC203 TIL therapy
- At least one evaluable tumor lesion
- Meet blood and chemistry test criteria within 7 days prior to enrollment (including white blood cell, neutrophil, lymphocyte counts, platelet count, hemoglobin, clotting times, kidney and liver function)
- Willing to use approved effective contraception if of child-bearing potential during treatment and for 1 year after lymphodepletion
- Ceased any malignant tumor-targeting therapies at least 28 days before TIL collection
- Able to understand and sign informed consent
- Committed to follow-up visit plan and study requirements
You will not qualify if you...
- Presence of other malignant tumors except for those cured, inactive for 5 years, or low recurrence risk malignancies
- Need for glucocorticoid treatment above 10mg prednisone daily or autoimmune diseases requiring immunomodulatory therapy
- Oxygen saturation below 95% at rest
- Active infections including HIV, HBV, HCV, syphilis
- Significant cardiovascular conditions including severe heart failure, low blood pressure, certain arrhythmias, or low ejection fraction
- Uncontrolled metabolic disorders or other serious systemic diseases
- Esophageal or gastric varices requiring immediate intervention or portal hypertension
- Severe liver disease including hepatic encephalopathy or liver failure
- Pulmonary fibrosis, interstitial lung disease, or acute lung disease
- Uncontrolled fluid effusions like pleural fluid or ascites
- Known untreated or uncontrolled central nervous system metastases except stable cases off certain medications
- Severe physical or mental illness
- Active systemic infection requiring treatment
- Recent or ongoing other cancer treatments within one month
- History of allogeneic T cell therapy
- Prior immunotherapy-related adverse events above grade 3
- Unresolved adverse events from previous anti-tumor treatments above grade 1
- Pregnant or breastfeeding females
- History of organ or stem cell transplantation, or renal replacement therapy
- Other severe systemic diseases or conditions unsuitable for the study as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive gene-edited GC203 Tumor Infiltrating Lymphocytes (TIL) infusion after lymphodepletion therapy including hydroxychloroquine and cyclophosphamide.
1 treatment visit followed by regular monitoring visits during treatment
Duration - Up to 36 months
Participants are monitored for safety and treatment response after the TIL infusion.
Regular visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
B
boyong shen
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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