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OncoMatch/Clinical Trials/NCT06828328

A Study of GC203 TIL in PDCA (RJ)

Is NCT06828328 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies GC203 TIL for pancreatic cancer.

Early Phase 1RecruitingShanghai Juncell TherapeuticsNCT06828328Data as of May 2026

Treatment: GC203 TILThis 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard treatment regimens

Test subjects have failed standard treatment regimens

Cannot have received: allogeneic T cell therapy

History of allogeneic T cell therapy

Cannot have received: allogeneic stem cell transplantation

History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy

Cannot have received: renal replacement therapy

History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy

Lab requirements

Blood counts

Absolute count of white blood cells ≥2.5×10^9/L; Absolute count of neutrophils ≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count ≥90×10^9; hemoglobin ≥90 g/L; Activated partial thromboplastin time (APTT) ≤1.5xULN (unless received anticoagulant therapy within the previous 3 days); International normalized ratio (INR) ≤1.5xULN (unless received anticoagulant therapy within the previous 3 days)

Kidney function

Serum creatinine ≤1.5mg/dL (or ≤132.6μmol/L), or clearance rate ≥50mL/min

Liver function

Serum ALT/AST ≤3×ULN (subjects with liver metastasis ≤3×ULN); Total bilirubin ≤1.5×ULN

Cardiac function

No NYHA Grade III or IV congestive heart failure, no clinically significant low blood pressure, no uncontrollable symptomatic coronary artery diseases, ejection fraction ≥35%; no severe cardiac rhythm and conduction anomaly (e.g., ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block)

Hematology and Chemistry(within 7 days prior to enrollment): Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count≥90×10^9; hemoglobin≥90 g/L; Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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