A Phase II Study Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
St. Jude Children's Research Hospital
Summary
The purpose of this study is to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients with newly diagnosed high-risk osteosarcoma who have undergone upfront standard chemotherapy. Primary Objectives: \- To evaluate 1-year RFS from the time of SJCARB7H3\_41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy. Secondary Objectives: * To evaluate the OS from time of SJCARB7H3\_41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy. * To evaluate the feasibility of delivering SJCARB7H3\_41BBL at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma. * To describe the safety of autologous SJCARB7H3\_41BBL therapy when delivered at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma.
Description
This is a phase 2 study of SJCARB7H3\_41BBL for participants with newly diagnosed high-risk metastatic osteosarcoma who received standard chemotherapy. All participants will receive standard chemotherapy (for example methotrexate, anthracycline, platinum), local control surgery, and pulmonary metastasectomy if applicable, and this is not considered part of protocol therapy. Participants will undergo apheresis prior to standard local control surgery (about 12 weeks after diagnosis) for SJCARB7H3\_41BBL manufacture and then resume standard consolidation therapy. A safety run will initiate with…
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant and/or legally authorized representative has signed the Informed Consent Form for this study 2. Prior cancer therapy: * Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior. * Regimen B only: has completed all planned cycles of consolidation chemotherapy at least 14 days prior and if clinically indicated, participant has undergone pulmonary metastasectomy. They must have recovered from any surgical complications with no ongoing sequelae of category 2 or higher by the Clavien-Dindo classification system and les…
Interventions
- DrugCyclophosphamide
IV
- DrugFludarabine
IV
- DrugMesna
IV prior to and again at 3, 6, and 9 hours following each dose of cyclophosphamide.
- ProcedureApheresis
IV collection
- ProcedureSJCARB7H3_41BBL infusion
1X107 CAR+ T cells/kg
Location
- St. Jude Children's Research HospitalMemphis, Tennessee