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

ConditionsRelapsed NeuroblastomaRefractory NeuroblastomaHigh-Risk NeuroblastomaGanglioneuroblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorBeijing Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • EB-DTNB-NK

    Biological/Vaccine

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: EB-DTNB-NKExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs) after first CARNK infusion, using protocol-defined DLT criteria.

Time frame
28 days
2

Incidence and severity of treatment-emergent adverse events

Incidence and severity of treatment-emergent adverse events, including CRS and ICANS, graded using CTCAE v5.0 and ASTCT consensus criteria.

Time frame
12 months

Secondary outcomes

1

Objective response rate by revised International Neuroblastoma Response Criteria (rINRC).

Time frame
12 months
2

Duration of response among responders

Time frame
24 months
3

Progression-free survival

Time frame
12 months
4

Overall survival

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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