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
Sponsors and collaborators
Robbie Majzner
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
National Institutes of Health (NIH)
Collaborator