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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Tumor Agnostic
Osteosarcoma
Rhabdomyosarcoma
Neuroblastoma
Sarcoma
Testicular Germ Cell Tumor
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04897321 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received standard first-line therapy.
Does this trial require CD276?
Yes, CD276 expression 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