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Clinical Trials in China / NCT07502287
Recruiting Phase 1/2

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

NCT07502287 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Biotech
Phase
Phase 1/2
Started
2026-03-02
Last updated
2026-03-30

Condition(s) studied

Relapsed NeuroblastomaRefractory NeuroblastomaHigh-Risk NeuroblastomaGanglioneuroblastoma

Investigational drug(s) / intervention(s)

EB-DTNB-NKFludarabineCyclophosphamide

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.

Study 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

Sex
ALL
Min age
12 Months
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: * Age 12 months to 21 years at consent/assent. * Histologically confirmed neuroblastoma or ganglioneuroblastoma with relapsed, refractory, progressive, or persistent high-risk disease for which no curative standard option is available. * Measurable or evaluable disease according to revised International Neuroblastoma Response Criteria (rINRC), including MIBG-avid disease, CT/MRI-evaluable soft-tissue disease, and/or bone marrow disease. * Tumor material available for central assessment of GD2 and B7-H3 expression; at least one target must be positive. GD2 is treated as the core target and B7-H3 as the complementary target for correlative target-prioritization analyses. * Prior exposure to standard neuroblastoma therapy, including anti-GD2-based therapy, unless contraindicated, unavailable, or declined for a documented medical reason. * Lansky or Karnofsky performance score \>= 50. * Life expectancy \>= 8 weeks. * Recovery from clinically significant acute toxicities of prior therapy and protocol-defined washout from chemotherapy, biologics, radiation, and prior cell therapy. * Adequate organ function: hematologic, renal, hepatic, cardiac, and pulmonary function considered sufficient by protocoldefined laboratory and clinical thresholds. * Negative pregnancy test for patients of childbearing potential and agreement to use effective contraception during the protocol-defined period. * Written informed consent from parent/legal guardian and assent from the participant when appropriate. Exclusion Criteria: * Active uncontrolled infection, including bacteremia, uncontrolled viral infection, or invasive fungal disease. * Pregnancy or breastfeeding. * Active grade \>= 2 graft-versus-host disease, or systemic immunosuppression for treatment/prevention of graft-versushost disease within the protocol-defined washout period after prior allogeneic transplant. * Symptomatic or unstable central nervous system disease requiring urgent medical intervention. * Prior genetically modified cellular therapy within the protocol-defined washout window, or unresolved clinically significant toxicity from prior cell therapy. * Active autoimmune disease requiring systemic immunosuppressive therapy. * Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, or neurologic disorder that would increase study risk. * Known hypersensitivity to fludarabine, cyclophosphamide, study-product components, or supportive-care medications required by the protocol. * Known uncontrolled HIV infection or uncontrolled hepatitis B or C. * Any medical, psychosocial, or logistical condition that, in the investigator's judgment, would make study participation unsafe or would impair protocol adherence.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong Recruiting

More Beijing Biotech trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07502287 on ClinicalTrials.gov ↗ ← All trials in China