B7-H3 CAR T Cell Therapy for Bone Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Julie Park, MD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Standard Chemotherapy
Participants receive standard chemotherapy including methotrexate, anthracycline, and platinum
Apheresis and CAR T Cell Manufacture
Participants undergo apheresis for SJCARB7H3_41BBL manufacture prior to local control surgery
Lymphodepletion and CAR T Cell Infusion
Participants receive lymphodepletion chemotherapy followed by SJCARB7H3_41BBL infusion
Follow-up
Participants are monitored for safety and effectiveness after CAR T cell infusion
What Are the Treatments Tested in This Trial?
Interventions
- SJCARB7H3_41BBL
How Is the Trial Designed?
1
Treatment groups
Experimental 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
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