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drugset / Trial / NCT07193628

B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma

NCT07193628 ↗

Phase 1 Recruiting 14 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is an investigator-initiated, open-label Phase I clinical trial designed to evaluate the safety and efficacy of EPC-003 fully human anti-B7H3/IL13Ra2 armored Chimeric Antigen Receptor T-Cell Therapy (CAR-T) cell injection in patients with recurrent or refractory glioblastoma. Approximately 14 patients with relapsed or refractory glioblastoma are planned to be enrolled in this trial. During the screening period (Days -28 to -15), subjects will undergo relevant examinations or observations to confirm the disease status, treatment history, and other related information. Subjects who meet the screening criteria will be enrolled in the clinical trial to receive EPC-003 treatment. Specifically, they will receive intraventricular injection of EPC-003 via Ommaya reservoir on Day 0 (D0), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), and Day 35 (D35), once a week, totaling 6 administrations. All CAR-T cell infusions will be delivered via intraventricular injection. This trial comprises two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.

Timeline

Start
2025-09-26
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject EPC-003 Cell therapy 2.5e+06 cells Other
Subject EPC-003 Cell therapy 5e+06 cells Other
Subject EPC-003 Cell therapy 1e+07 cells Other
Subject EPC-003 Cell therapy 2e+07 cells Other

Indications

glioblastoma