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NCT07428993 · ClinicalTrials.gov registry record · Phase 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
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT07428993 is a Phase 2 study that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 41 participants.
The verdict
NCT07428993, a Phase 2 study, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- PROCEDURE Apheresis
- PROCEDURE SJCARB7H3_41BBL infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2026-06 |
| Est. Completion | 2035-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07428993
The ClinicalTrials.gov registry entry for NCT07428993 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07428993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07428993 about?
NCT07428993 is a clinical study titled "Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma". 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 SJC...
What is the current status of trial NCT07428993?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2026-06. Estimated completion is 2035-12.
What interventions are being tested in trial NCT07428993?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), Apheresis (PROCEDURE), SJCARB7H3_41BBL infusion (PROCEDURE).
Who is sponsoring clinical trial NCT07428993?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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