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Relapsed NeuroblastomaPhase 1/2DUAL-NK-NBNCT07502287

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

A Phase 1/2 study testing EB-DTNB-NK, Fludarabine and Cyclophosphamide in people with Relapsed Neuroblastoma and Refractory Neuroblastoma, run by Beijing Biotech at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 12 months to 21 years
What is being tested?
EB-DTNB-NK, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
2 Mar 2026to 17 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seni S Lu, Phd contact

+86 13076790030

Seni-Lu@beijing-biotech.com

China1 site, 1 recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com

    Recruiting

Other trials in China

About this study

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

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

Read the 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 expands at the RP2D in a biomarker-characterized population. All participants undergo central review of tumor tissue or marrow for GD2 and B7-H3 expression before treatment. Patients receive protocol-defined lymphodepletion followed by CAR-NK infusion on Day 0, with optional additional infusions on Days 7 and 14 if there is no dose-limiting toxicity (DLT), uncontrolled cytokine release syndrome (CRS), or rapid progression. Formal disease assessment uses revised International Neuroblastoma Response Criteria (rINRC). Correlative studies assess CAR-NK expansion and persistence, cytokine kinetics, tumor-response associations with antigen density, and whether future development should remain dualtarget or shift toward a GD2-dominant or B7-H3-enriched strategy. Long-term follow-up for gene-modified cellular therapy is planned per local regulatory requirements.

Being tested
EB-DTNB-NK, Fludarabine, Cyclophosphamide
Keywords
pediatric neuroblastoma, CAR-NK, GD2, B7-H3, CD276, dual-targeting, relapsed/refractory, allogeneic, solid tumor immunotherapy, cell therapy, biomarkerinformed design
Medical subject headings
Neuroblastoma, Ganglioneuroblastoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EB-DTNB-NKBiological

    Also called Dual-target GD2/B7-H3 CAR-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.

  • FludarabineDrug

    Also called Flu

    Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-defined conditioning regimen.

  • CyclophosphamideDrug

    Also called Cy

    Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-definedb conditioning regimen.

Study groups in NCT07502287
Study groupRoleWhat they receive
EB-DTNB-NKExperimentalParticipants 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.
Receives: Biological: EB-DTNB-NK; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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.

    Measured: 12 months

Secondary outcomes (4)

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

    Measured: 12 months

  2. Duration of response among responders

    Measured: 24 months

  3. Progression-free survival

    Measured: 12 months

  4. Overall survival

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start2 Mar 2026
  3. Primary completion14 Mar 2027 (estimated)
  4. Study completion17 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, open-label, biomarker-informed study with Part A (standard 3+3 dose-escalation) followed by Part B (dose expansion at the RP2D). All treated participants receive the same investigational dual-target CAR-NK product after baseline assessment of GD2 and B7-H3 expression. Biomarker analyses are prespecified to explore which antigen profile appears most suitable for later-stage development.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07502287
Sponsor's protocol ID
EB-CARNK-CRC-103
Acronym
DUAL-NK-NB
Status last verified
Mar 2026
First submitted
25 Mar 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EB-DTNB-NK, Fludarabine and Cyclophosphamide in people with Relapsed Neuroblastoma and Refractory Neuroblastoma, run by Beijing Biotech at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) after first CARNK infusion, using protocol-defined DLT criteria. (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07502287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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