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Siplizumab-based Conditioning for Hematopoietic Stem Cell Transplantation in Patients With Advanced Sickle Cell Disease (CD2 SCD)
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.
Phase I/II label single arm safety assessment study of Siplizumab-based conditioning. It is designed to determine the safety and feasibility of hematopoietic stem cell transplantation for patients with advanced sickle cell disease using in vivo T cell depletion with Siplizumab. It is a three-stage design with a target sample size of at most 18 patients. At the first stage, a total of 6 patients will be recruited, the study will be stopped, if 2 or more of patients experience any of the following events: graft failure/Grade 3-4 acute GVHD/death in the first 100 days. If not, the study will proceed to the second stage and recruit additional 6 patients. The study will be stopped if 4 or more patients experience an event as specified above among the 12 patients. If not, the study will proceed to the third stage and recruit additional 6 patients, the study will be stopped any time if 6 or more patients experience an event among the 18 patients. The study will be stopped at any time if a patient death occurs.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Columbia University Irving Medical Center
New York, New York, United States
Start Date
September 28, 2023
Primary Completion Date
December 11, 2024
Completion Date
December 11, 2025
Last Updated
February 27, 2026
1
ACTUAL participants
Siplizumab
DRUG
Exchange Transfusion
PROCEDURE
Total Body Irradiation
PROCEDURE
Stem Cell Infusion
PROCEDURE
Cyclophosphamide 50mg
DRUG
Mesna
DRUG
Sirolimus Oral Tablet
DRUG
Rituximab or Biosimilar
DRUG
Lead Sponsor
Columbia University
Collaborators
NCT06250595
NCT02286154
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04170348