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.
1: Agree to comply with the trial treatment plan and visit schedule, voluntarily enroll in the trial, and sign the informed consent form in writing.
1: The lesion is located in the posterior fossa structures such as the cerebellum, pons, and medulla oblongata.
Parallel
EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1)
Biological/Vaccine2.5 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.
EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 2)
Biological/Vaccine5 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.
EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 3)
Biological/Vaccine10 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.
EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 4)
Biological/Vaccine20 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.
The incidence of grade 3-4 adverse events (AEs) related to B7H3/IL13Ra2 CAR-T therapy.
The incidence of grade 3-4 adverse events (AEs) related to B7H3/IL13Ra2 CAR-T therapy assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria .
Objective response rate (ORR) within 12 months of the follow-up period
Overall Response Rate (ORR) is calculated by summing the percentages of patients who achieve a complete response (CR) and those who attain a partial response (PR).
Duration of response (DOR) within 12 months of the follow-up period
Duration of Response (DOR) is defined as the time from the first assessment confirming Complete Response (CR) or Partial Response (PR) of the tumor to the first assessment indicating Progressive Disease (PD) or death from any cause.
Disease control rate (DCR) within 12 months of the follow-up period
Disease Control Rate (DCR) is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Progression-Free Survival (PFS) within 12 months of the follow-up period
Progression-Free Survival (PFS) is defined as the time from the initiation of cell infusion to the first assessment of tumor progression or death from any cause.
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