Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in P… (NCT07428993) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
United States41 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Participant and/or legally authorized representative has signed the Informed Consent Form for this study
✓. Prior cancer therapy:
✓. 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, will be considered ambulatory for purposes of assessing performance status
✓. Adequate organ function as indicated by:
✓. Laboratory values meet the following criteria:
✓. 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.
Exclusion criteria
What they're measuring
1
Event-free survival (EFS), defined as time from SJCARB7H3_41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death
Timeframe: Time from SJCARB7H3_41BBL infusion to time of first event, followed up to 24-months post-infusion
✕. 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:
✕. Participant has received prior disease-directed therapy other than 1st line therapy with methotrexate, an anthracycline, and a platinum and local control surgery
✕. Pregnant or breastfeeding
✕. Presence of any condition that, in the opinion of the investigator, would prohibit the participant from undergoing treatment under this protocol