OncoMatch/Clinical Trials/NCT06590246
A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)
Is NCT06590246 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Armored and GPC3-targeted autologous CAR T-cell for hepatocellular carcinoma.
Treatment: Armored and GPC3-targeted autologous CAR T-cell — This single-arm, open-label multicenter Phase I/II study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/recurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: GPC3 positive (positive by ihc)
Disease stage
Required: Stage BCLC STAGE B, BCLC STAGE C, CNLC STAGE II, CNLC STAGE III (BCLC, CNLC)
BCLC stage C or B (not amenable to surgery/local treatment...) or stage II-III (not amenable to surgery/local treatment...) per China liver cancer staging (CNLC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: car-t therapy
Cannot have received: gpc3-targeted therapy
Lab requirements
Blood counts
ANC ≥1.0×10^9/L; Absolute Lymphocyte count ≥ 0.3×10^9/L; Platelet count ≥ 75×10^9/L; Hemoglobin ≥ 80g/L; no transfusion or blood component transfusion within 28 days prior to blood sampling or within 14 days prior to apheresis; no G-CSF or other hematopoietic stimulators within 28 days prior to blood sampling or within 21 days prior to apheresis
Kidney function
Calculated creatinine clearance ≥30ml/min (Cockcroft-Gault equation)
Liver function
Child-Pugh score ≤ 6; Serum total bilirubin ≤ 2.5×ULN (or ≤ 3×ULN if Gilbert's syndrome); AST and ALT ≤5×ULN; Albumin ≥ 2.8 g/dL
Cardiac function
LVEF ≥45% (echocardiography, non-impaired, within 28 days prior to apheresis); Prothrombin time INR ≤1.6
Child-Pugh score ≤ 6... LVEF ≥45%... Prothrombin time INR ≤1.6... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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