Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma (NCT07502287) | Clinical Trial Compass
RecruitingPhase 1/2
Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma
China36 participantsStarted 2026-03-02
Plain-language 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
Who can participate
Age range12 Months – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs) after first CARNK infusion, using protocol-defined DLT criteria.
Timeframe: 28 days
2
Incidence and severity of treatment-emergent adverse events