OncoMatch/Clinical Trials/NCT07222735
Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas
Is NCT07222735 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Fludarabine and Cyclophosphamide for sarcoma.
Treatment: Fludarabine · Cyclophosphamide · B7-H3-CAR T Cells — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Biomarker criteria
Required: CD276 overexpression (H score ≥ 100 by IHC)
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
Prior therapy
Must have received: standard first-line therapy
Evidence of relapsed...or refractory...disease after standard first-line therapy
Cannot have received: systemic steroid therapy
Exception: ≤ 0.5 mg/kg/day methylprednisolone equivalent or stopped ≥ 7 days prior to CAR T cell infusion
Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone, < 7 days prior to CAR T cell infusion
Cannot have received: systemic therapy
Exception: stopped ≥ 14 days prior to start of protocol therapy
Receiving systemic therapy < 14 days prior to start of protocol therapy, which will interfere with the activity of the CAR product (in the opinion of the study PIs)
Cannot have received: radiation therapy
Exception: stopped ≥ 4 weeks prior to start of protocol therapy
Received radiation therapy within the 4 weeks prior to start of protocol therapy
Lab requirements
Blood counts
Hemoglobin ≥ 7g/dL (can be transfused); Platelet count ≥ 50,000/μL (can be transfused); ANC ≥ 1000/μL
Kidney function
Serum creatinine not exceeding age-based maximums (1 to <2 years: 0.6; 2 to <6 years: 0.8; 6 to <10 years: 1; 10 to <13 years: 1.2; 13 to <16 years: male 1.5, female 1.4; ≥ 16 years: male 1.7, female 1.4)
Liver function
Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; ALT or AST ≤5 times the upper limit of normal for age
Cardiac function
Echocardiogram with left ventricular ejection fraction ≥ 50%
Adequate cardiac function defined by echocardiogram with left ventricular ejection fraction ≥ 50%; Adequate renal function as defined by not exceeding the maximum serum creatinine listed below by age; Adequate pulmonary function defined as pulse oximetry ≥ 92% on room air; Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age; Hemoglobin ≥ 7g/dL (can be transfused); Platelet count ≥ 50,000/μL (can be transfused); Absolute neutrophil count (ANC) ≥ 1000/μL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Jude Children's Research Hospital · Memphis, Tennessee
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