Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients W… (NCT07487402) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma
China27 participantsStarted 2026-03-30
Plain-language summary
A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.
Who can participate
Age range19 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age \>18 years and ≤75 years, male or female.
* Histologically confirmed recurrent or metastatic hepatocellular carcinoma (HCC) that is not amenable to surgical resection.
* At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* Tumor tissue must test positive for GPC3 expression by immunohistochemical (IHC), defined as \> 25% of tumor cells staining for GPC3 in the pathological specimen. Preferably, the target lesion sample should be used, including freshly obtained tumor tissue or archival tissue samples deemed acceptable by the investigator.
* Expected survival ≥ 12 weeks.
* Child-Pugh class A.
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-1.
* For subjects who are HBsAg or HBcAb positive, HBV-DNA must be \< 2 000 IU/mL; HBsAg-positive patients must receive antiviral therapy according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition).
* Adequate venous access for leukapheresis or venous blood collection.
* Hematologic parameters: WBC ≥ 2.5 × 10⁹/L, platelets ≥ 60 × 10⁹/L, Hb ≥ 9.0 g/dL, lymphocytes ≥ 0.4 × 10⁹/L.
* Biochemical parameters: Serum albumin ≥ 30 g/L; Lipase and amylase ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN and estimated creatinine clearance ≥ 40 mL/min; ALT and AST ≤ 5 × ULN; serum total bilirubin ≤ 2.5 × ULN; prothrombin time ≤ 4s longer above normal.
* Women or childbearing potential must have a neg…
What they're measuring
1
Adverse Events (AEs)
Timeframe: Within 2 years post Meta10-GPC3 infusion.