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OncoMatch/Clinical Trials/NCT06375187

A Study of GC203 TIL in Advanced Malignant Solid Tumors

Is NCT06375187 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Engineering Tumor Infiltrating Lymphocytes for solid tumor.

Phase 1RecruitingShanghai Juncell TherapeuticsNCT06375187Data as of May 2026

Treatment: Engineering Tumor Infiltrating LymphocytesA clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Breast Carcinoma

Colorectal Cancer

Gastric Cancer

Hepatocellular Carcinoma

Pancreatic Cancer

Cholangiocarcinoma

Esophageal Carcinoma

Non-Small Cell Lung Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard therapy

have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy [including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery])

Cannot have received: systemic antitumor therapy

Patients who have received systemic antitumor therapy within 4 weeks.

Cannot have received: allogeneic T cell therapy

Participants who have had a history of allogeneic T cell therapy

Cannot have received: gene engineering autologous cell therapy

gene engineering autologous cell therapy within 1 years

Lab requirements

Blood counts

Absolute Neutrophil Count (ANC) ≥1.0×10^9/L; Absolute Lymphocyte Count (ALC) ≥0.5×10^9/L; Platelet ≥80×10^9/L

Kidney function

Serum Creatinine (Scr) ≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance ≥60mL/min; Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g

Liver function

AST/SGOT ≤3×ULN; ALT/SGPT ≤3×ULN; Total Bilirubin (TBIL) ≤1.5×ULN

Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function: * Absolute Neutrophil Count (ANC)≥1.0×10^9/L; * Absolute Lymphocyte Count(ALC)≥0.5×10^9/L; * Platelet≥80×10^9/L; * International Normalized Ratio(INR)≤1.5×ULN; * Activated Partial Thromboplastin Time(APTT)≤1.5×ULN; * Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min * Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g; * Alanine aminotransferase(AST/SGOT) ≤3×ULN; * Alanine aminotransferase (ALT/SGPT) ≤3×ULN; * Total Bilirubin(TBIL)≤1.5×ULN;

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

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