RecruitingPhase 2NCT07428993

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

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


Sponsor

St. Jude Children's Research Hospital

Enrollment

41 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Apheresis, a drug called Cyclophosphamide, and others for people with pediatric osteosarcoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT07428993