drugset / Trial / NCT07390539

B7-H3.CD28Z.CART in CNS Neoplasms

NCT07390539 ↗

Phase 1 Not yet recruiting 70 enrolled Robbie Majzner National Institutes of Health (NIH) · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

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)

Timeline

Start
2026-07
Primary completion
2030-08-31
Completion
2032-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject B7-H3.CD28Z.CART Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous