Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma

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

Trial Details

NCT ID
NCT07428993
Phase
PHASE2
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • Cyclophosphamide
  • Fludarabine
  • Mesna
  • Apheresis
  • SJCARB7H3_41BBL infusion
Locations (sample)
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • 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 …

For full eligibility, visit ClinicalTrials.gov.

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