RecruitingPancreatic CancerPancratic Ductal AdenocarcinomaTreatment Side Effects
A Study of GC203 TIL in PDCA (RJ)
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Shanghai Juncell Therapeutics
You may qualify if…
- ✓ 1. have done the tumor resection for gene-edited GC203 TIL production and successfully produced；
- ✓ 2. Age: 18 years to 70 years;
- ✓ 3. Histologically diagnosed as pancreatic ductal adenocarcinoma;
- ✓ 4. Expected life-span more than 3 months;
- ✓ 5. ECOG score 0-1;
- ✓ 6. Test subjects have failed standard treatment regimens, and be willing to recieve gene-edited GC203 TIL therapy;
- ✓ 7. At least 1 evaluable tumor lesion;
- ✓ 8. Hematology and Chemistry（within 7 days prior to enrollment）:
You may not qualify if…
- ✕ 1. with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
- ✕ 2. Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
- ✕ 3. Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%;
- ✕ 4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
- ✕ 5. Significant cardiovascular anomalies according to any of the following definition:
- ✕ New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
- ✕ 6. Uncontrolled metabolic disorders, such as diabetes, which is known to be uncontrolled, or other non-malignant organ or systemic disease or cancer secondary reactions, can lead to higher medical risk and/or uncertainty in the evaluation of survival;
- ✕ 7. Patients with esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy) or who, in the opinion of the investigator or in consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegalgia on imaging) or a history of varicose bleeding must undergo endoscopic evaluation within the first 3 months of enrollment;
Source: ClinicalTrials.gov · NCT06828328 · last updated 2026-08-05