RecruitingPhase 1Phase 2NCT07502287

Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma

A Phase 1/Phase 2, Open-Label Study of BiomarkerInformed, Allogeneic Dual-Target GD2/B7-H3 (CD276) CAR-NK Cells in Children and Young Adults With Relapsed or Refractory Neuroblastoma


Sponsor

Beijing Biotech

Enrollment

36 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This illustrative Phase 1/Phase 2 study tests allogeneic dual-target GD2/B7-H3 (CD276) CAR-NK cells in children and young adults with relapsed or refractory neuroblastoma. After lymphodepletion, participants receive IV CAR-NK cells;Part A defines the RP2D and Part B estimates preliminary activity


Eligibility

Min Age: 12 MonthsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a biological treatment called EB-DTNB-NK, and others for people with ganglioneuroblastoma, high risk neuroblastoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Months to 21 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEB-DTNB-NK

Allogeneic, cord blood-derived NK cells engineered with a dual-target CAR recognizing GD2 and B7-H3 (CD276), with IL-15 support and an inducible safety switch; administered intravenously on Day 0 with optional repeat dosing on Days 7 and 14 if tolerated.

DRUGFludarabine

Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-defined conditioning regimen.

DRUGCyclophosphamide

Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-definedb conditioning regimen.


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07502287


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