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

StatusRecruiting
PhasePhase 2
Started2026-09
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from St. Jude Children's Research Hospital

Amendment history

2026-08-28
Study Status, Study Description, Arms and Interventions, Outcome Measures v4
Primary endpoint(s) modified1 entry, revised
WasEvent-free survival (EFS), defined as time from SJCARB7H3_41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death
NowEvent-free survival (EFS), defined as time from SJCARB7H3-41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death
Start date2026-06→2026-09
Secondary endpoints3 entries, revised
Overall survival (OS), defined as time from SJCARB7H3_41BBLSJCARB7H3-41BBL cell infusion to all-cause mortality. Number of participants with successful manufacture of SJCARB7H3_41BBLSJCARB7H3-41BBL cells of sufficient dose and planned product administration
Study description-4 characters
This is a phase 2 study of SJCARB7H3_41BBLSJCARB7H3-41BBL for participants with newly diagnosed high-risk metastatic [...] local control surgery (about 12 weeks after diagnosis) for SJCARB7H3_41BBLSJCARB7H3-41BBL manufacture and then resume standard consolidation therapy. [...] imen A. For Regimen A, eligible participants with available SJCARB7H3_41BBLSJCARB7H3-41BB product will receive lymphodepletion chemotherapy 14-28 day [...] andard chemotherapy (31 weeks after diagnosis), followed by SJCARB7H3_41BBLSJCARB7H3-41BB infusion. If Regimen A is not cleared, then Regimen B will be evaluated, where lymphodepletion [...] [...]
2026-05-18
Study Status, Contacts/Locations v3
Recruitment opened
Study sitescontacts updated at 1 of 1 site
2026-05-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2026-04-21
Study Status v1
Start date2026-02→2026-06
2026-02-17
Original filing
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.
Trial Details
NCT Number NCT07428993
Lead Sponsor St. Jude Children's Research Hospital
Conditions Pediatric Osteosarcoma
Enrollment 41 participants
Start Date 2026-09
Primary Completion 2034-12 (estimated)
Study Completion 2035-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-01