eligibility_summary
Pediatric (1–12 y, ≥10 kg) relapsed/refractory neuroblastoma, consent, PR/SD at entry, ≥1 evaluable lesion by MIBG/bone marrow (soft tissue ≤2 cm), B7‑H3+ tumor, Lansky >60, life expectancy >12 wks, adequate organ/marrow function, prior toxicities ≤G1. Exclude: other recent cancers, symptomatic CNS mets, MIBG‑non‑avid, organ transplant, active autoimmune/immunodef, uncontrolled disease/infection (TB/HIV), recent therapy/surgery/vaccine/trial, prior gene therapy, allergy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Chimeric Natural Killer Receptor–Universal T cells (CNK-UT), an allogeneic, gene-modified cellular immunotherapy (engineered T cells). Mechanism: T cells are equipped with a chimeric NK receptor that redirects them to tumor-associated ligands and activates T-cell cytotoxic signaling (via ITAM/CD3ζ), promoting perforin/granzyme-mediated killing and cytokine release against neuroblastoma. Targets: B7-H3–expressing neuroblastoma cells (enrollment requires B7-H3 by IHC), engaging NK-receptor–driven activation pathways and T-cell effector functions, intended to overcome immune evasion in refractory/relapsed disease. Design: Phase 1, single-arm dose escalation/expansion with IV infusions (single then multiple doses, 3–34×10^7 CNK+ cells/kg). Objectives: safety, preliminary efficacy, and cellular pharmacokinetics.