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
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.
• Participant and/or legally authorized representative has signed the Informed Consent Form for this study
• 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 less than 6 weeks must have passed from time of pulmonary metastasectomy.
• No evidence of progressive disease since enrolled on study
• Lansky performance status score of ≥ 50 for participants \<16 years of age or Karnofsky score ≥ 50 for participants ≥ 16 years. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status
• Adequate organ function as indicated by:
‣ Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) based on enrollment eligibility table.
⁃ Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL AND ALT (SGPT) ≤ 5 times ULN
⁃ Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram
⁃ Respiratory: Oxygen saturation ≥ 90% on room air without supplemental oxygen or mechanical ventilation
• Laboratory values meet the following criteria:
‣ Absolute Neutrophil Count (ANC) ≥ 750 cells/uL
⁃ Platelet Count of ≥ 75,000 (can be transfused)
⁃ Hemoglobin ≥ 7 g/dL (can be transfused)
• Participant is ≥ 7 days from receiving supra-physiologic dosing of systemic (IV or PO) corticosteroids. Glucocorticosteroid physiologic replacement therapy for management of adrenal insufficiency is allowed.
• Participant and/or legally authorized representative has signed the Informed Consent Form for the treatment phase of this study.