Engineered immune cells injected directly into brain show promise for kids with deadly tumors
NCT ID NCT03500991
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether specially engineered immune cells (CAR T cells) can be safely given directly into the brain or spinal fluid of children and young adults with HER2-positive brain tumors that have come back or not responded to standard treatments. The therapy aims to control the disease by targeting and killing tumor cells from inside the brain. Ten participants will receive weekly doses for two 3-week cycles, with close monitoring for side effects and tumor response.
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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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10 people
The number who actually took part.
- Started
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Jul 2018
- Expected to finish
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Jul 2039
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. Histologically diagnosed HER2-positive Central Nervous System (CNS) tumor 3. Evidence of refractory or recurrent CNS disease for which there is no standard therapy 4. Able to tolerate apheresis, or has apheresis product available for use in manufacturing 5. CNS reservoir catheter, such as an Ommaya or Rickham catheter 6. Life expectancy ≥ 8 weeks 7. Lansky or Karnofsky score ≥ 60 8. If patient does not have previously obtained apheresis product, patient must have 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 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 cell 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. 9. Adequate organ function 10. Adequate laboratory values 11. Patients of childbearing/fathering potential must agree to use highly effective contraception Exclusion Criteria: 1. Diagnosis of classic diffuse intrinsic pontine glioma (DIPG) 2. Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention 3. Presence of primary immunodeficiency/bone marrow failure syndrome 4. Presence of clinical and/or radiographic evidence of impending herniation 5. Presence of active malignancy other than the primary CNS tumor under study 6. Presence of active severe infection 7. Pregnant or breastfeeding 8. Subject and/or authorized legal representative unwilling or unable to provide consent/assent for participation in the 15-year follow up period 9. 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.
Contacts and locations
Locations
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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