A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

April 7, 2028

Conditions
Advanced Hepatocellular Carcinoma (HCC)
Interventions
BIOLOGICAL

Super Hi-TCR-T cells

"Intravenous infusion of 3.0×10⁶ cells/kg of Super Hi-TCR-T cells targeting Nectin4, NKG2DL, TROP2, B7H3, GPC3, and FAP.~The expression levels of Nectin4, NKG2DL, TROP2, B7H3, GPC3 and FAP were detected by immunohistochemistry. Meanwhile, 20ml peripheral blood was extracted to evaluate the quality of T cells. Patients with positive expression rates of at least 2 targets (excluding FAP) \>10% and qualified T cell quality could be considered for inclusion.~Peripheral blood lymphocytes were collected and Hi-TCR-T cells targeting three targets (including FAP) were prepared. After pretreatment with fludarabine + cyclophosphamide chemotherapy (FC regimen), the prepared Hi-TCR-T cells were transfused back, in which the dose of Hi-TCR-T cells at each target was 3.0x106 cells/kg body weight (the dose was the extended therapeutic dose obtained in the previous clinical trial), and the drug was administered by peripheral intravenous infusion."

Trial Locations (1)

200438

RECRUITING

The Third Affiliated Hospital of Navy Military Medical University, Shanghai

All Listed Sponsors
lead

Eastern Hepatobiliary Surgery Hospital

OTHER

NCT06902389 - A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter