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Engineered immune cells take on childhood cancers in first human test

NCT ID NCT03618381

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage trial tests a new type of immunotherapy for children and young adults with solid tumors that have not responded to standard treatments. The therapy uses the patient's own immune cells (T cells) that are genetically modified to recognize and attack cancer cells carrying a protein called EGFR. The study will enroll 44 participants to evaluate safety, find the best dose, and see if the cells can shrink tumors. Some participants will receive cells that also target a second protein (CD19) to help the immune cells work longer.

What this could mean

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

Active substance
EGFR806 CAR T cells (genetically modified immune cells)
What this could lead to
If successful, this could point toward a new treatment option for children and young adults with hard-to-treat solid tumors that have come back or not responded to standard therapy.
What could go wrong
This is an early Phase 1 trial with only 44 participants, so it is primarily testing safety and dosing. The treatment may not shrink tumors, and there are risks of serious side effects like 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

Phase 1

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

Participants

About 44 people

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

Started

Jun 2019

Expected to finish

Jun 2040

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 30 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: * First 2 subjects enrolled and treated in both Arm A and Arm B: age ≥ 15 and ≤ 30 years * Subsequent subjects: age ≥ 1 and ≤30years * Histologically diagnosed malignant, non-CNS solid tumor expressing EGFR * Evidence of refractory or recurrent disease * Able to tolerate apheresis or has apheresis product available for use in manufacturing * Life expectancy ≥ 8 weeks * Lansky or Karnofsky score ≥ 50 * Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy * If no apheresis product or T cell product is available,≥ 7 days post last chemotherapy/biologic therapy administration * If no apheresis product or T cell product is available,≥ 3 half lives or 30 days, whichever is shorter, post last dose of anti-tumor antibody therapy (including check point inhibitor) * Prior genetically modified cell therapy is allowed if not detectable at enrollment. * If no apheresis product or T cell product is available,≥ 6 weeks post last dose of myeloablative therapy and allogeneic or autologous stem cell transplant * Subjects who receive autologous stem cell infusion following non-myeloablative therapy are eligible once all other eligibility requirements are met * If no apheresis product or T cell product is available,≥ 7 days post last systemic corticosteroid therapy (physiologic replacement dosing is allowed) * If no apheresis product or T cell product is available, subjects with neuroblastoma must be ≥ 12 weeks from I131 MIBG therapy. * Adequate organ function * Adequate laboratory values * Patients of childbearing potential must agree to use highly effective contraception Exclusion Criteria: * Presence of active malignancy other than primary malignant solid tumor diagnosis * Current relevant CNS pathology * Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment * Presence of active severe infection * Presence of primary immunodeficiency syndrome * Receiving external beam radiation therapy at time of enrollment * Receiving any anti-cancer agents or chemotherapy * Pregnant or breastfeeding * Unwilling to provide consent/assent for participation in the study and 15 year follow up period * 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.