Recruiting
Phase 2

B7-H3 CAR T Cell

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07428993

Conditions

Pediatric Osteosarcoma

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Fludarabine

Mesna

Apheresis

SJCARB7H3_41BBL infusion

Study Details

Brief summary:

The purpose of this study is to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients with newly diagnosed high-risk osteosarcoma who have undergone upfront standard chemotherapy.

Primary Objectives:

\- To evaluate 1-year RFS from the time of SJCARB7H3-41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy.

Secondary Objectives:

  • To evaluate the OS from time of SJCARB7H3-41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy.
  • To evaluate the feasibility of delivering SJCARB7H3-41BBL at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma.
  • To describe the safety of autologous SJCARB7H3-41BBL therapy when delivered at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma.

Conditions

Pediatric Osteosarcoma

Study ID

NCT07428993

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

41 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3CAR4OS Treatment

All patients will receive standard of care chemotherapy, which is not considered part of protocol therapy. Eligible patients will undergo apheresis prior to standard local control surgery for CAR T cell manufacture and then resume standard therapy. In the absence of progressive disease, eligible patients with available SJCARB7H3-41BBL product will receive lymphodepletion chemotherapy (fludarabine/cyclophosphamide) after the completion of standard chemotherapy, followed by SJCARB7H3-41BBL infusion. Pulmonary metastasectomy will be performed as indicated according to the standard of care and will be timed after (Regimen A) or before (Regimen B) lymphodepletion and SJCARB7H3-41BBL infusion. Following successful clearance of either regimen A or, if necessary, regimen B, the efficacy cohort will be initiated.

Interventions

Cyclophosphamide

IV

Fludarabine

IV

Mesna

IV prior to and again at 3, 6, and 9 hours following each dose of cyclophosphamide.

Apheresis

IV collection

SJCARB7H3 41BBL infusion

1X107 CAR+ T cells/kg

Primary outcome measure

  • Event-free survival (EFS), defined as time from SJCARB7H3-41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death [ Time Frame: Time from SJCARB7H3-41BBL infusion to time of first event, followed up to 24-months post-infusion ]

Central Contacts and Locations

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105-2794

Contacts

Principal Investigator:

Julie Park, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Osteosarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-09-01.