OncoMatch/Clinical Trials/NCT07193628
B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma
Is NCT07193628 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1) and EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 2) for refractory glioblastoma.
Treatment: EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1) · EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 2) · EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 3) · EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 4) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: CD276 overexpression (>30%)
The positive expression rate of B7H3 > 30%
Required: IL13RA2 overexpression (>30%)
The positive expression rate of IL13RA2 > 30%
Prior therapy
Must have received: radiotherapy — postoperative
Disease progression or recurrence after standard treatment (postoperative radiotherapy combined with concurrent and adjuvant chemotherapy with temozolomide)
Must have received: chemotherapy (temozolomide) — concurrent and adjuvant
Disease progression or recurrence after standard treatment (postoperative radiotherapy combined with concurrent and adjuvant chemotherapy with temozolomide)
Cannot have received: B7H3/IL13RA2-targeted therapy
Subjects who have previously received treatment targeting B7H3/IL13Ra2
Cannot have received: gene therapy
Subjects who have previously received gene therapy or cell therapy
Cannot have received: cell therapy
Subjects who have previously received gene therapy or cell therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Subjects who have previously received allogeneic hematopoietic stem cell transplantation
Cannot have received: autologous hematopoietic stem cell transplantation
those who are eligible for and agree to undergo autologous hematopoietic stem cell transplantation
Cannot have received: anti-tumor therapy
Exception: within 4 weeks prior to cell infusion or within 5 half-lives of the drug (whichever is shorter)
Subjects who have received anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, TTfield therapy, investigational trial drugs, and other anti-tumor treatments) within 4 weeks prior to cell infusion or within 5 half-lives of the drug (whichever is shorter)
Cannot have received: radiotherapy
Exception: within 12 weeks prior to cell infusion (unless progressive disease outside the irradiated field or pseudo-progression can be excluded)
Subjects who have received radiotherapy within 12 weeks prior to cell infusion (those with progressive disease outside the irradiated field or those in whom pseudo-progression after radiotherapy/chemotherapy can be excluded are eligible for enrollment)
Lab requirements
Blood counts
ANC ≥ 1.5×10⁹/L; Platelet Count ≥ 100×10⁹/L; Absolute Lymphocyte Count ≥ 0.3×10⁹/L; Hemoglobin ≥ 8.0 g/dL
Kidney function
Serum creatinine ≤ 1.6 × ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
Serum total bilirubin (T-Bil) ≤ 1.5 × ULN; for patients without liver involvement, AST and ALT ≤ 3 × ULN; for patients with liver involvement, ALT and AST ≤ 5 × ULN
Cardiac function
Left ventricular ejection fraction > 50%
adequate organ function, meeting the following laboratory test criteria: ... (see full text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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