Engineered immune cells take on childhood cancer in new trial
NCT ID NCT06803875
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests a new treatment called hALK.CAR T cells for children and young adults with high-risk neuroblastoma that has returned or not responded to standard treatments. The therapy involves taking a patient's own immune cells, engineering them to recognize and attack cancer cells that have a protein called ALK, and giving them back. The study has two phases: first, finding the safest dose, and second, seeing how well it works in 42 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hALK.CAR T cells (a type of immune cell therapy that targets a protein called ALK on cancer cells)
- What this could lead to
- If this works, it could offer a new treatment option for children with hard-to-treat neuroblastoma that has come back or not responded to standard therapy.
- What could go wrong
- This is an early-phase trial (phase 1/2) with only 42 participants, so it is too soon to know if it will be effective. There are also risks of side effects from the cell therapy, such as cytokine release syndrome.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 months to 29 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age ≥ 12 months and \< 30 years at the time of consent. The first patient on each dose level will need to be age ≥ 6 years old 2. Disease Status: 1. Patients must have histologic verification of neuroblastoma at diagnosis or at relapse 2. Patients must have high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification at time of study enrollment 3. Patients must have persistent/refractory or relapsed disease for which standard curative measures are no longer effective, as defined in the protocol 4. Patients must have evaluable or measurable disease per the revised International Neuroblastoma Response Criteria (INRC) 3. Adequate washout from prior treatment regimens 4. Adequate organ function 5. Adequate performance status defined as Lansky or Karnofsky performance score ≥50% 6. Subjects of reproductive potential must agree to use acceptable birth control methods 7. Signed informed consent Exclusion Criteria: 1. Pregnant or nursing (lactating) women 2. Patients with uncontrolled active infection 3. Patients who are concurrently receiving other investigational agents 4. Patients who have received prior CART-cell or other gene-modified immune-effector cell therapy, are not eligible unless they are \>8 weeks from time of infusion, have fully recovered from any associated toxicities and have documented lack of persistence of the product 5. Patients with a known additional malignancy other than non-melanomatous skin cancer or carcinoma in situ, unless not requiring active treatment and stable or disease-free for at least 3 years 6. Uncontrolled CNS metastasis 7. CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement which may impair the ability to evaluate neurotoxicity 8. History of severe hypersensitivity reaction to compounds used in the study 9. HIV/HBV/HCV infection 10. Patients receiving systemic steroid therapy (physiologic replacement, inhaled steroids and premedication for blood products are allowed) 11. Primary immunodeficiency or history of systemic autoimmune disease requiring systemic immunosuppression/disease modifying agents within the last 2 years 12. Uncontrolled intercurrent illness 13. Inability to comply with the study requirements
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Universal donor immune cells tested against tough childhood cancer
- Can we help parents make better choices for children with cancer?
- Slowing down immunotherapy infusion may reduce pain in children with Tough-to-Treat neuroblastoma
- Immunotherapy boosts chemo against tough childhood cancer
- Supercharged immune cells take aim at childhood cancers
- New antibody combo shows promise in tough childhood cancer