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Engineered immune cells aim to stop bone Cancer's return in kids

NCT ID NCT07428993

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 41 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2035

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

Up to 21 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. 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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105-2794, United States

    Contact Email: •••••@•••••

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