Clinical Trial

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

Recruiting Phase 1
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Summary
RAD3CAR is a phase I study designed to evaluatethe safety of B7-H3-CAR T cells and lymphodepletion in combination with hypofractionated radiation therapy. Primary objective: \- To evaluate the safety of B7-H3-CAR T cell therapy after priming with hypofractionated radiation therapy (HFRT) and lymphodepleting chemotherapy in patients ≤ 21 years of age with relapsed/refractory B7-H3+ sarcomas. Secondary objectives: * To describe the antitumor activity of B7-H3-CAR T cells in combination with HFRT * To determine if B7-H3-CAR T cells traffic to tumor sites after combination treatment with HFRT
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-28; most recent amendment 2026-02-06.
Status change: Not Yet Recruiting → Recruiting 2025-11-18
Trial Details
NCT Number NCT07222735
Lead Sponsor St. Jude Children's Research Hospital
Conditions Sarcoma, Childhood Osteosarcoma, Childhood Rhabdomyosarcoma, Childhood Soft Tissue Sarcoma, Ewing Sarcoma
Enrollment 42 participants
Start Date 2026-01-21
Primary Completion 2030-11-05 (estimated)
Study Completion 2031-11-05 (estimated)
Updated on ClinicalTrials.gov 2026-02-09