drugset / Trial / NCT07015684

131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)

NCT07015684

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find the smallest amount of the 131 I-apamistamab needed for preparing patients with severe sickle cell disease (SCD) for a bone marrow transplant. This is the first time 131 I-apamistamab is being used for advanced Sickle Cell Disease (SCD) in the setting of allogeneic stem cell transplant. 131 I-apamistamab is an investigational product. This means that 131 I-apamistamab has not been approved by the Food and Drug Administration (FDA) for medical use in patients. The study treatment that is given before the transplant is called the conditioning regimen. In this study, the investigators are adding a drug called 131 I-apamistamab instead of the conditioning regimen typically given before a stem cell transplant.

Timeline

Start
2025-04-28
Primary completion
2030-03-12
Completion
2032-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject IODINE I 131 APAMISTAMAB Monoclonal antibody 0.5 mg/kg Intravenous
Subject IODINE I 131 APAMISTAMAB Monoclonal antibody 3700 mbq Intravenous
Subject IODINE I 131 APAMISTAMAB Monoclonal antibody 5550 mbq Intravenous
Background Alemtuzumab Monoclonal antibody 1 mg/kg Intravenous
Background Sirolimus Small molecule Oral

Indications