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Engineered immune cells injected directly into brain show promise for kids with deadly tumors

NCT ID NCT03500991

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Jul 2039

An estimate. End dates often move.

Lead sponsor

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

1 year to 26 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: 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

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.