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NCT06442761 · ClinicalTrials.gov registry record · Phase 1
SCD Stem Cell Mobilization and Apheresis Using Motixafortide
A Phase 1 study of Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT06442761 is a Phase 1 study of Sickle Cell Disease that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 15 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06442761, a Phase 1 study of Sickle Cell Disease, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Motixafortide
Study Locations (2)
Alabama
- University of Alabama at Birmingham - Birmingham
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-11-14 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06442761
The ClinicalTrials.gov registry entry for NCT06442761 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (95% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Motixafortide is the first listed.
NCT06442761 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06442761 about?
NCT06442761 is a clinical study titled "SCD Stem Cell Mobilization and Apheresis Using Motixafortide". 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...
What is the current status of trial NCT06442761?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-11-14. Estimated completion is 2028-07.
What conditions does trial NCT06442761 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06442761?
The interventions under investigation include: Motixafortide (DRUG).
Who is sponsoring clinical trial NCT06442761?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06442761 being conducted?
This trial has 2 study locations across Alabama, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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