B7-H3.CD28Z.CART in CNS Neoplasms

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-21
SponsorRobbie Majzner

About this trial

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)

Eligibility criteria

Qualifiers

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.

Medulloblastoma

Atypical Teratoid Rhabdoid Tumor (ATRT)

Embryonal Tumor with Multilayered Rosettes (ETMR) Pineoblastoma

Disqualifiers

Tumor with diameter of >5cm in one dimension on T2/FLAIR sequence

Tumor with evidence of clinically significant midline shift or uncal herniation

Tumor that, in opinion of the site investigator, shows significant mass effect in either the brain or spine

Participants with clinical or radiological evidence of brain herniation.

Trial design

Treatments tested in this trial

  • B7-H3.CD28Z.CART
  • Fludarabine
  • Cyclophosphamide

Treatment groups

70 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Robbie Majzner

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

National Institutes of Health (NIH)

Collaborator