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

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.

NCT Number	NCT07015684
Lead Sponsor	Columbia University Collaborators: Actinium Pharmaceuticals
Conditions	Sickling Disorder Due to Hemoglobin S
Enrollment	24 participants
Start Date	2025-04-28
Primary Completion	2030-03-12 (estimated)
Study Completion	2032-03-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-10