B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
Trial Parameters
Brief Summary
This is an open label, non-randomized, single site Phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3CART into the central nervous system of adult subjects with recurrent IDH wild-type GBM using a standard 3+3 dose escalation design.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed high grade (WHO Grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with PNET features, tested as IDH wild-type, as per revised WHO 2021 criteria. Patients must also have evidence of tumor recurrence/progression by MRI (RANO criteria) after standard front-line therapy. b. First recurrence or progressive disease after a standard line therapy. * Resectable disease: Resection is being considered as part of the standard of care for the patient and it is thought that it is feasible that a majority of contrast-enhancing tumor mass/signal can be resected. * Patients must be between the ages of 18 and 75 years old (inclusive). * Karnofsky Performance score ≥ 60. * Use of steroids must be limited to ≤ 4 mg of decadron daily. * Adequate organ function at time of screening visit including: 1. Hgb ≥ 12 g/dL (male) or ≥ 11.5 g/dL (females) 2. ANC ≥ 1500/uL 3. Platelets ≥ 100