Engineered immune cells aim to stop bone Cancer's return in kids
NCT ID NCT07428993
First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This phase II trial tests whether a single infusion of B7-H3 CAR T cells, given after standard chemotherapy, can prevent the return of high-risk osteosarcoma in children. The study will enroll 41 participants who have completed upfront chemotherapy. Researchers will monitor how long participants stay cancer-free and track any side effects from the cell therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B7-H3 CAR T cells (a type of immune cell therapy)
- What this could lead to
- If successful, this could offer a new way to prevent osteosarcoma from coming back after standard chemotherapy, potentially improving long-term survival for children with this aggressive cancer.
- What could go wrong
- This is a small, early-phase trial (41 participants) testing a complex cell therapy. It may not work for everyone, and there are risks of serious side effects like cytokine release syndrome or neurological problems. The long-term benefits are still unknown.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2035
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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Up to 21 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. Participant and/or legally authorized representative has signed the Informed Consent Form for this study 2. Prior cancer therapy: * Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior. * Regimen B only: has completed all planned cycles of consolidation chemotherapy at least 14 days prior and if clinically indicated, participant has undergone pulmonary metastasectomy. They must have recovered from any surgical complications with no ongoing sequelae of category 2 or higher by the Clavien-Dindo classification system and less than 6 weeks must have passed from time of pulmonary metastasectomy. 3. No evidence of progressive disease since enrolled on study 4. Lansky performance status score of ≥ 50 for participants \<16 years of age or Karnofsky score ≥ 50 for participants ≥ 16 years. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status 5. Adequate organ function as indicated by: * Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) based on enrollment eligibility table. * Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL AND ALT (SGPT) ≤ 5 times ULN * Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram * Respiratory: Oxygen saturation ≥ 90% on room air without supplemental oxygen or mechanical ventilation 6. Laboratory values meet the following criteria: * Absolute Neutrophil Count (ANC) ≥ 750 cells/uL * Platelet Count of ≥ 75,000 (can be transfused) * Hemoglobin ≥ 7 g/dL (can be transfused) 7. Participant is ≥ 7 days from receiving supra-physiologic dosing of systemic (IV or PO) corticosteroids. Glucocorticosteroid physiologic replacement therapy for management of adrenal insufficiency is allowed. 8. Participant and/or legally authorized representative has signed the Informed Consent Form for the treatment phase of this study. Exclusion Criteria: 1. Major surgical adverse event related to the primary tumor local control defined as Clavien-Dindo category 3 requiring ongoing wound care. 2. Evidence of clinically significant encephalopathy/new focal neurologic deficits. 3. Presence of active severe infection, defined as: * positive blood culture within 48 hours of enrollment, OR * fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment 4. Participant has received prior disease-directed therapy other than 1st line therapy with methotrexate, an anthracycline, and a platinum and local control surgery • Regimen B only - okay to have undergone initial pulmonary metastasectomy 5. Pregnant or breastfeeding 6. Presence of any condition that, in the opinion of the investigator, would prohibit the participant from undergoing treatment under this protocol
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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St. Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105-2794, United States
Contact Email: •••••@•••••
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