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B7-H3.CD28Z.CART

B7-H3.CD28Z.CART in CNS Neoplasms

  • RegistryNCT07390539
  • PhasePhase 1
  • StatusRecruiting
  • ConditionCentral Nervous System Neoplasms
  • SponsorRobbie Majzner
How B7-H3.CD28Z.CART works1 min

The drug

What is being tested.

Autologous CAR T cells targeting B7-H3 (CD276), administered intravenously (into the vein) per protocol.

Lymphodepleting chemotherapy administered intravenously per institutional standards.

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.

The study

How the trial runs.

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)

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • 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:
  • 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)

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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