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Tests treatment safety and results for Pediatric Osteosarcoma
Official title Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
ClinicalTrials.gov ID: NCT07428993
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric osteosarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- Participant and/or legally authorized representative has signed the Informed Consent Form for this study
- 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...
- No evidence of progressive disease since enrolled on study
You likely can't join if
- 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...
See the full eligibility criteria
- Participant and/or legally authorized representative has signed the Informed Consent Form for this study
- 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...
- No evidence of progressive disease since enrolled on study
- 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...
- 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
- 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)
- 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.
- Participant and/or legally authorized representative has signed the Informed Consent Form for the treatment phase of this study.
- 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
- Pregnant or breastfeeding
- Presence of any condition that, in the opinion of the investigator, would prohibit the participant from undergoing treatment under this protocol
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.