RecruitingPhase 1NCT06442761

SCD Stem Cell Mobilization and Apheresis Using Motixafortide

Sickle Cell Disease Stem Cell Mobilization and Apheresis Using Motixafortide


Sponsor

St. Jude Children's Research Hospital

Enrollment

15 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if the study drug, motixafortide, is safe in participants with sickle cell disease (SCD). Investigators also want to see if the drug will help the body increase the number of stem cells that can be collected for possible future transplant use. PRIMARY OBJECTIVE * To characterize the safety and tolerability of motixafortide in participants with SCD as determined by the incidence of adverse events (AEs). SECONDARY OBJECTIVES * To characterize the efficacy of a single dose (Part A) or two doses (Part B) of motixafortide for hematopoietic stem cell (HSC) mobilization and apheresis collection in participants with SCD as determined by the yield of CD34+ cells (CD34+ cells/kg). * To measure the mobilization effects of single-day (Part A) or daily dosing (Part B) dosing with motixafortide in the peripheral blood in participants with SCD as determined by peak peripheral blood CD34+ counts * To recommend a phase 2 dosing strategy based on safety, efficacy, and mobilization effects


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Motixafortide for people with sickle cell disease. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMotixafortide

Given Subcutaneously (under the skin).


Locations(3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

National Heart, Blood and Lung Institute-Cellular and Molecular Therapy Branch

Bethesda, Maryland, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06442761


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