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 (Jun 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
Treatments studied
Chemotherapy
Other
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07222735 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic steroid therapy, systemic therapy, radiation therapy disqualifies patients from enrollment.
Does this trial require CD276?
Yes, CD276 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages