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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06590246 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior car-t therapy, gpc3-targeted therapy disqualifies patients from enrollment.
Does this trial require GPC3?
Yes, GPC3 positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage BCLC STAGE B or BCLC STAGE C or CNLC STAGE II or CNLC STAGE III is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages