Robbie Majzner
The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy. The names of the study investigational therapies involved in this study are: * Fludarabine (a type of chemotherapy) * Cyclophosphamide (a type of chemotherapy) * B7-H3 CAR T cells (a type of cellular therapy)
This is a single-institution, Phase 1/1b, open-label study to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent/recurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy. The U.S. Food and Drug Administration (FDA) has not approved B7-H3 CAR T cells as a treatment for any disease. Fludarabine and…
Pre-screening Inclusion Criteria: * Participants must have histologically and/or molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent/progressive following standard of care treatment. --Eligible CNS embryonal tumor types include: * Medulloblastoma * Atypical Teratoid Rhabdoid Tumor (ATRT) * Embryonal Tumor with Multilayered Rosettes (ETMR) Pineoblastoma * Other CNS embryonal tumor types, at the discretion of the study chair (or designee) * Participants must have adequate pre-trial tumor material available to determine B7- H3 ex…
Autologous CAR T cells targeting B7-H3 (CD276), administered intravenously (into the vein) per protocol.
Lymphodepleting chemotherapy administered intravenously per institutional standards.
Lymphodepleting chemotherapy administered intravenously per institutional standards.