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Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
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
Details
| Lead sponsor | St. Jude Children's Research Hospital |
|---|---|
| Phase | PHASE1 |
| Status | RECRUITING |
| Enrolment | 42 |
| Start date | Wed Jan 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Nov 05 2031 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Sarcoma
- Childhood Osteosarcoma
- Childhood Rhabdomyosarcoma
- Childhood Soft Tissue Sarcoma
- Ewing Sarcoma
Interventions
- Fludarabine
- Cyclophosphamide
- B7-H3-CAR T Cells
- Radiation Therapy
Countries
United States