Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
St. Jude Children's Research Hospital
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
Description
This study is a phase I study designed to describe the safety of B7-H3-CAR T cells and lymphodepletion in combination with hypofractionated radiation therapy for the treatment of pediatric patients with B7-H3+ sarcoma. The study will contain two-part eligibility criterion: one to proceed with autologous apheresis and manufacturing of CAR T cells, and a second to proceed with CAR T cell treatment. The primary intervention is the administration of autologous B7-H3-CAR T cells, after priming with HFRT and administration of lymphodepleting chemotherapy. Peripheral blood mononuclear cells (PBMC)…
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION 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 considered B7-H3 positive with a H score greater than or equal to 100 * Osteosarcoma * Ewing Sarcoma * Rhabdomyosarcoma Non-rhabdomyosarcoma soft tissue sarcomas * Evidence of relapsed (cancer that has completely responded \[i.e., no evidence of disease using standard imagin…
Interventions
- DrugFludarabine
Intravenously on day -5, -4, -3 and -2
- DrugCyclophosphamide
Intravenously on day -3, -2
- DrugB7-H3-CAR T Cells
Intravenously on day 0
- RadiationRadiation Therapy
5 or 8 treatment sessions (fractions), scheduled to complete on Day -2
Location
- St. Jude Children's Research HospitalMemphis, Tennessee