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

NCT07193628 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1)

2.5 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.

BIOLOGICAL

EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 2)

5 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.

BIOLOGICAL

EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 3)

10 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.

BIOLOGICAL

EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 4)

20 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Feng Yan, MD & PhD · Department of Neurosurgery, the Second Affiliated Hospital of Zhejiang University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193628 on ClinicalTrials.gov