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Evaluating B7-H3 CAR T Cells for High-Risk Osteosarcoma

This study is testing a new treatment called SJCARB7H3_41BBL, a type of CAR T cell therapy, for children and young adults (up to 21 years old) with newly diagnosed high-risk osteosarcoma (a type of bone cancer). You would have already completed standard chemotherapy before joining. The main goal is to see how long patients live without their cancer returning or getting worse after receiving the SJCARB7H3_41BBL infusion. Researchers also want to understand how safe and practical it is to give this treatment after standard therapy. The study is currently unclear on its recruitment status, but plans to enroll 41 participants.

Study design
This is an interventional study, planning to enroll 41 participants. It is a phase 2 study, meaning it aims to further evaluate the treatment's effectiveness and safety.
What's involved
You would undergo apheresis (a procedure to collect blood cells) to create the SJCARB7H3_41BBL product, followed by lymphodepletion chemotherapy (Cyclophosphamide, Fludarabine, Mesna) and then the SJCARB7H3_41BBL infusion. You would have regular check-ups to monitor your health and the cancer's status.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months (2 years) after the SJCARB7H3_41BBL infusion to track their health and cancer status.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07428993

Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma

Recruiting
PHASE2Up to 21InterventionalTreatment
St. Jude Children's Research Hospital
~41 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabineMesnaApheresisSJCARB7H3_41BBL infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS), defined as time from SJCARB7H3_41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death
Measured over Time from SJCARB7H3_41BBL infusion to time of first event, followed up to 24-months post-infusion

Conditions

Pediatric Osteosarcoma

Explore related trials

Osteosarcoma

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Julie Park, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Julie Park, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Event-free survival (EFS), defined as time from SJCARB7H3_41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or deathTime from SJCARB7H3_41BBL infusion to time of first event, followed up to 24-months post-infusion

    Event-free participants will be censored at the time of last follow-up. This analysis will report the Kaplan-Meier (KM) curve, along with the 12-month EFS estimate and its 80% confidence interval using the arcsine-square root transformation. Evaluable participants are those who complete standard chemotherapy, receive SJCARB7H3\_41BBL and are treated on the regimen used for the Efficacy phase.