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NOT YET RECRUITING
NCT07428993
PHASE2

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 21 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2026-02

Completion Date

2035-12

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

IV

DRUG

Fludarabine

IV

DRUG

Mesna

IV prior to and again at 3, 6, and 9 hours following each dose of cyclophosphamide.

PROCEDURE

Apheresis

IV collection

PROCEDURE

SJCARB7H3_41BBL infusion

1X107 CAR+ T cells/kg

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States