Clinical Trial
Study Details
Plerixafor subcutaneous injection will be administered prior to apheresis.
Busulfan IV infusion will be administered as myeloablative conditioning therapy.
BIVV003 will be administered as an IV infusion following myeloablative conditioning with busulfan.
This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.
Study Overview
Subject participation in this study will be approximately 136 weeks. Enrolled subjects will be asked to participate in a separate long-term follow-up study to monitor the safety and efficacy of BIVV003 treatment for a total of 15 years post-transplant.
Contacts and Locations
UCSF Benioff Children's Hospital
Oakland, California 94609
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30322
United States
Investigational Site Number 101
Bethesda, Maryland 20892
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States