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

Sponsor
Beijing Biotech
Study ID
NCT07502287
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • EB-DTNB-NK — BIOLOGICAL
    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 — DRUG
    Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-defined conditioning regimen.
  • Cyclophosphamide — DRUG
    Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-definedb conditioning regimen.

Study Details

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

Key Dates

Start date
Mar 2, 2026
Status verified
Mar 2026
Primary completion
Mar 14, 2027
Completion
Jun 17, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EB-DTNB-NK
    Participants receive protocol-defined fludarabine/cyclophosphamide lymphodepletion followed by intravenous allogeneic dual-target GD2/B7-H3 CAR-NK cells on Day 0 at the assigned dose level or RP2D. Additional doses on Days 7 and 14 are permitted if predefined safety criteria are met and there is no prohibitive toxicity or rapid progression.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) after first CARNK infusion, using protocol-defined DLT criteria. [ Time Frame: 28 days ]

Central Contacts

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