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Engineered immune cells take aim at childhood cancer

NCT ID NCT07502287

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment for children and young adults with neuroblastoma that has returned or not responded to standard care. The treatment uses specially engineered immune cells from donated cord blood that are designed to recognize and attack two different markers on the cancer cells. Participants receive chemotherapy first to prepare their immune system, then the engineered cells are given intravenously. The study aims to find the safest dose and see if the treatment can shrink tumors or slow the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
engineered immune cells (CAR-NK cells) that target two proteins on cancer cells
What this could lead to
If it works, this could offer a new treatment option for children with neuroblastoma that has come back or not responded to other therapies.
What could go wrong
This is an early-phase trial with only 36 participants, so it may not work for everyone. There are risks of side effects like immune reactions or organ damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 months to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 participant when appropriate. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518036, China

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