Engineered immune cells take aim at childhood brain cancers
NCT ID NCT04185038
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether a new type of immunotherapy, called B7-H3 CAR T cells, can be safely given directly into the brain or spinal fluid of children and young adults with aggressive brain tumors like DIPG, DMG, or other recurrent central nervous system cancers. The treatment uses the patient's own immune cells, which are modified in a lab to recognize and attack tumor cells. The goal is to see if this approach is safe and feasible, and to gather early information on how the cells spread and work in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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May 2042
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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1 year to 26 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 ≥ 1 and ≤ 26 years 2. Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy 3. Able to tolerate apheresis, or has apheresis product available for use in manufacturing 4. CNS reservoir catheter, such as an Ommaya or Rickham catheter 5. Life expectancy ≥ 8 weeks 6. Lansky or Karnofsky score ≥ 60 7. If patient does not have previously obtained apheresis product, patient must have discontinued, and recovered from acute toxic effects of, all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment: 1. ≥ 7 days post last chemotherapy/biologic therapy administration 2. 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy 3. Must be at least 30 days from most recent cellular infusion 4. All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg/m2/day. Corticosteroid physiologic replacement therapy is allowed. 8. Adequate organ function 9. Adequate laboratory values 10. Patients of childbearing/fathering potential must agree to use highly effective contraception Exclusion Criteria: 1. Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention 2. Presence of primary immunodeficiency/bone marrow failure syndrome 3. Presence of clinical and/or radiographic evidence of impending herniation 4. Presence of \>Grade 3 dysphagia 5. Presence of active malignancy other than the primary CNS tumor under study 6. Presence of active severe infection 7. Receiving any anti-cancer agents or chemotherapy 8. Pregnant or breastfeeding 9. Subject and/or authorized legal representative unwilling or unable to provide consent/assent for participation in the 15 year follow up period 10. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol
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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
1 site. 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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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radioactive gel aimed straight at childhood brain tumors