Engineered immune cells take aim at childhood cancers in early trial
NCT ID NCT04483778
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a personalized cell therapy for children and young adults (up to age 26) with solid tumors that have come back or not responded to standard treatment. The therapy uses the patient's own immune cells, modified to recognize and attack a protein called B7H3 found on many solid tumors. The main goals are to check safety, find the best dose, and see if the cells can persist 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 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Dec 2040
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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0 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: * Participants age ≤ 26 years at the time of consent for study participation; the first 2 participants enrolled and treated with CAR T cells in both Arms A and B will be ≥ 15 years. and ≤ 26 years at time of consent for study participation * Histologically diagnosed malignant, non-primary CNS solid tumor * Evidence of refractory or recurrent disease * Lansky or Karnofsky score ≥ 50 * Life expectancy ≥ 8 weeks * Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy and radiotherapy * If no apheresis product or usable T cell product is available, all chemotherapy has been discontinued ≥ 7 days prior to enrollment * If no apheresis or usable T cell product is available, all biologic therapy has been discontinued ≥ 7 days prior to enrollment * If no apheresis product or T cell product is available, all systemic corticosteroid therapy has been discontinued ≥ 7 days prior to enrollment (physiologic replacement dosing is allowed) * If no apheresis product or usable T cell product is available, at least 3 half-lives or 30 days (whichever is shorter) from time of last dose of anti-tumor directed antibody therapy (including checkpoint inhibitor) at time of enrollment * If no apheresis product or usable T cell product is available, at least 6 weeks post last dose of myeloablative therapy and autologous and/or allogeneic stem cell transplant, or non-myeloablative therapy and allogeneic stem cell transplant (all timed from stem cell infusion). Participants who receive autologous stem cell infusion following non-myeloablative therapy are eligible once all other eligibility requirements are met. * If no apheresis product or usable T cell product is available, participants who have received genetically modified cell therapy must be at least 30 days from most recent cell infusion prior to enrollment * If no apheresis product or usable T cell product is available, participants with neuroblastoma must be at least 12 weeks from I131 MIBG therapy. * Adequate organ function * Adequate laboratory values * Participant is able to tolerate apheresis (including placement of temporary apheresis catheter, if necessary), or already has an apheresis product available for use in manufacturing. * Participants 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 * Receiving external beam radiation therapy at time of enrollment * Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment * Participant is pregnant or breastfeeding * Participant has presence of active severe infection * Participant has presence of any condition that, in the option of an investigator, would prohibit the participant from undergoing treatment under this protocol * Participant has primary immunodeficiency syndrome * Unwilling or unable to provide consent/assent for participation in the study and 15 year follow up period
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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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