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Clinical Trial NCT07502287 (DUAL-NK-NB) for Relapsed Neuroblastoma, Refractory Neuroblastoma, High-Risk Neuroblastoma, Ganglioneuroblastoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma (DUAL-NK-NB) Phase 1, Phase 2 36 Pediatric

Recruiting
Clinical Trial NCT07502287 (DUAL-NK-NB) is designed to study Treatment for Relapsed Neuroblastoma, Refractory Neuroblastoma, High-Risk Neuroblastoma, Ganglioneuroblastoma. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 2 March 2026, with plans to enroll 36 participants. Led by Beijing Biotech, it is expected to complete by 17 June 2028. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
Brief 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
Detailed Description
The investigational product in this example is a cord blood-derived allogeneic NK-cell therapy engineered to express a dual-target CAR recognizing GD2 and B7-H3, supported by IL-15 to improve short-term persistence and equipped with an inducible safety switch. The study is designed as a multicenter Phase 1/Phase 2 protocol: Part A uses a standard 3+3 dose-escalation approach across predefined dose levels, and Part B ...Show More
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

Conditions
Relapsed NeuroblastomaRefractory NeuroblastomaHigh-Risk NeuroblastomaGanglioneuroblastoma
Other Study IDs
  • DUAL-NK-NB
  • EB-CARNK-CRC-103
NCT ID Number
NCT07502287
Start Date (Actual)
2026-03-02
Last Update Posted
2026-03-30
Completion Date (Estimated)
2028-06-17
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Keywords
pediatric neuroblastoma
CAR-NK
GD2
B7-H3
CD276
dual-targeting
relapsed/refractory
allogeneic
solid tumor immunotherapy
cell therapy
biomarkerinformed design
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEB-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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of dose-limiting toxicities (DLTs) after first CARNK infusion, using protocol-defined DLT criteria.
28 days
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.
12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective response rate by revised International Neuroblastoma Response Criteria (rINRC).
12 months
Duration of response among responders
24 months
Progression-free survival
12 months
Overall survival
24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
12 Months
Eligible Sexes
All
  • 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.

  • 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.
Beijing Biotech logoBeijing Biotech
Study Central Contact
Contact: Seni S Lu, Phd, +86 13076790030, [email protected]
1 Study Locations in 1 Countries

Guangdong

Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China
Zhen J Peng, Phd, Contact, +86 13076790039, [email protected]
Recruiting