OncoMatch/Clinical Trials/NCT06500819
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
Is NCT06500819 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies B7-H3CART Dose (Intravenous) for neuroblastoma.
Treatment: B7-H3CART Dose (Intravenous) — The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and/or refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Sarcoma
Osteosarcoma
Biomarker criteria
Allowed: CD276 expression analysis required
B7-H3 positive expression on malignant cells is NOT required but archival tissue must be available, or the subject must be willing to undergo tissue biopsy for expression analysis.
Allowed: SLC18A2 MIBG avidity
neuroblastoma which may have MIBG positive disease only
Prior therapy
Must have received: anti-GD2 antibody therapy — neuroblastoma
Subjects with neuroblastoma must have received or be intolerant to anti-GD2 antibody therapy.
Must have received: ifosfamide or cyclophosphamide plus etoposide therapy or alternative salvage regimen (ifosfamide, cyclophosphamide, etoposide) — Wilms tumor
Subjects with Wilm's tumor must have received or be intolerant to ifosfamide or cyclophosphamide plus etoposide therapy or alternative salvage regimen.
Must have received: Adriamycin-based therapy (doxorubicin) — embryonal rhabdomyosarcoma
Subjects with embryonal rhabdomyosarcoma must have received or be intolerant to Adriamycin-based therapy.
Must have received: surgical resection of metastatic nodules — surgically resected pulmonary osteosarcoma in first recurrence
Subjects with surgically resected pulmonary osteosarcoma in first recurrence must have received surgical resection of metastatic nodules.
Lab requirements
Blood counts
ANC ≥ 750/uL; Platelet count ≥ 75,000/uL; Absolute lymphocyte count ≥ 150/uL; cytopenias due to disease are permitted
Kidney function
Creatinine within institutional norms for age (≤ 2 mg/dL in adults or age-based cutoffs in children) OR creatinine clearance ≥ 60 mL/min
Liver function
Serum ALT/AST ≤ 2.5x ULN (unless elevated ALT/AST is associated with disease involvement of the liver, in which case this criterion will be waived); Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac function
Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by ECHO, no clinically significant ECG findings
Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Palo Alto, California
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