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Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma
Sponsor: Beijing Biotech
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
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.
Fludarabine
Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-defined conditioning regimen.
Cyclophosphamide
Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-definedb conditioning regimen.
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China