OncoMatch/Clinical Trials/NCT04897321
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
Is NCT04897321 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Fludarabine and Cyclophosphamide for pediatric solid tumor.
Treatment: Fludarabine · Cyclophosphamide · MESNA · B7-H3 CAR T cells — 3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Osteosarcoma
Rhabdomyosarcoma
Neuroblastoma
Sarcoma
Testicular Germ Cell Tumor
Glioblastoma
Melanoma
Biomarker criteria
Required: CD276 expression (H-score ≥100 by IHC)
B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100
Prior therapy
Must have received: standard first-line therapy
Evidence of relapsed or refractory disease after standard first-line therapy
Lab requirements
Blood counts
Hemoglobin ≥ 7g/dL (can be transfused); Platelet count >50,000/uL (can be transfused); Absolute neutrophil count (ANC) ≥ 1000/uL
Kidney function
creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if < 2 years of age)
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 a ventricular ejection fraction >40%; or shortening fraction ≥25%
Echocardiogram with a ventricular ejection fraction >40%; or shortening fraction ≥25%; Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml/min/1.73m2 (GFR 40 ml/min/1.73m2 if < 2 years of age); Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value; 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/uL (can be transfused); Absolute neutrophil count (ANC) ≥ 1000/uL
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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