Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Recruiting
Phase 2
Interventional Study
Pediatric Osteosarcoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 21
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 41 (estimated)
- Sponsor
- St. Jude Children's Research Hospital · Other
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About 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 standa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participant and/or legally authorized representative has signed the Informed Consent Form for this study
2. Prior cancer therapy:
* Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior.
* Regimen B only: has completed all plann…
Contacts