Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
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.
Timeline
- Start
- 2026-06
- Primary completion
- 2034-12
- Completion
- 2035-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |