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

Trial Details

NCT ID
NCT07222735
Phase
PHASE1
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • Fludarabine
  • Cyclophosphamide
  • B7-H3-CAR T Cells
  • Radiation Therapy
Locations (sample)
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • \*a previously collected, autologous leukapheresis product can be used for T cell production
  • Collection and manufacturing eligibility
  • Age ≤ 21 years old
  • B7-H3+ sarcoma; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using any previously obtained biopsy; a tumor is consider…

For full eligibility, visit ClinicalTrials.gov.

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