Phase 2: testing Cyclophosphamide for Pediatric Osteosarcoma
This study wants 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.
Official registry: https://clinicaltrials.gov/study/NCT07428993 · St. Jude Children's Research Hospital · enrollment listed as 41
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Cyclophosphamide, Fludarabine, or Mesna. The registry lists allocation as na. This study wants 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.
They plan to enroll about 41 people at Memphis. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Phase II Study Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Interventions: Cyclophosphamide, Fludarabine, Mesna, Apheresis, SJCARB7H3_41BBL infusion
Primary outcome (registry wording): Event-free survival (EFS), defined as time from SJCARB7H3-41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death
Who it is for (from inclusion criteria)
- Ages any to 21 Years
- Prior cancer therapy:
- Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior
- No evidence of progressive disease since enrolled on study
- 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
Who the registry excludes
- Major surgical adverse event related to the primary tumor local control defined as Clavien-Dindo category 3 requiring ongoing wound care
- Evidence of clinically significant encephalopathy/new focal neurologic deficits
- 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
- 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
Public study contact (from the registry)
Julie Park, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- St. Jude Children's Research Hospital — Memphis, Tennessee (recruiting)
FAQ about this NCT record
Is NCT07428993 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07428993?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07428993?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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