drugset / Trial / NCT06078696
Siplizumab for Sickle Cell Disease Transplant
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find out whether siplizumab is safe and effective for patients with SCD undergoing an allogeneic transplant and to prevent development of Graft versus Host Disease (GVHD) and graft failure. The main goals of this study are : * To determine if acute GVHD occurs and how severe the acute GVHD is in subjects receiving the study drug * To determine if graft failure occurs in subjects receiving the study drugs In this study, participants will receive 5 infusions of the study drug, siplizumab, while getting a stem cell transplant for SCD. Before siplizumab infusion, participants will be given medications to reduce the risks of allergic reaction to the drug.
Timeline
- Start
- 2023-09-28
- Primary completion
- 2024-12-11
- Completion
- 2025-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Siplizumab | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 50 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Sirolimus | Small molecule | 4 mg | Oral |