Robbie Majzner
The goal of this research study is to test if a new cell therapy (B7-H3.CD28Z.CART / B7-H3 CAR T cells) is safe and effective in treating children and young adults with solid cancers whose tumors have returned or stopped responding to standard treatments (relapsed or refractory) and have been identified with a B7-H3 marker. The names of the treatment interventions used in this study are: * B7-H3.CD28Z.CART / B7-H3 CAR T cells * Fludarabine * Cyclophosphamide
This is a Phase I, open-label, single-center, dose-escalation study testing the safety and effectiveness of a new cell therapy B7-H3.CD28Z.CART / B7-H3 CAR T cells in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3. The B7-H3 protein is found in high levels on many pediatric solid tumors (like neuroblastoma, osteosarcoma, and others), this cell therapy uses genetically altered blood cells as an investigational cell product designed to recognize, bind to and help kill cells that express B7-H3. This is the first time that these specific B7-H3 CAR…
Inclusion Criteria: Eligibility Criteria for Prescreening Purpose of prescreening is to establish B7-H3 expression by IHC performed at Boston Children's Hospital. This can be performed at any time prior to completing the protocol screening process. Participants who meet the following criteria, will be offered participation in the full screening process and protocol enrollment, if eligible: * Participants must have histologically confirmed diagnosis of a solid tumor that is relapsed or refractory for which standard curative measures do not exist or are no longer effective. * Participant must…
Modified autologous T cells administered via Intravenous (IV) infusion
Administered intravenously
Administered intravenously
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