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RECRUITING
NCT07502287
PHASE1/PHASE2

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

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

12 Months - 21 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03-02

Completion Date

2028-06-17

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-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.

DRUG

Fludarabine

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

DRUG

Cyclophosphamide

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

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China