Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Sponsor: St. Jude Children's Research Hospital • ClinicalTrials.gov ID: NCT07428993
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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.
Interventions
-
Cyclophosphamide
(Drug)
IV
-
Fludarabine
(Drug)
IV
-
Mesna
(Drug)
IV prior to and again at 3, 6, and 9 hours following each dose of cyclophosphamide.
-
Apheresis
(Procedure)
IV collection
-
SJCARB7H3_41BBL infusion
(Procedure)
1X107 CAR+ T cells/kg
Eligibility criteria
Conditions
Locations
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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