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NCT05618301 · ClinicalTrials.gov registry record · Phase 1
Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05618301 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 10 participants.
The verdict
NCT05618301, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate the therapeutic product, and currently available mobilization regimens carry unacceptable risk for patients with SCD or do not reliably yield optimal numbers of HSCs for gene therapy. The investigators hypothesize that HSC mobilization with motixafortide (CXCR4i) alone and the combination of motixafortide plus natalizumab (VLA-4i) will be safe and tolerable in SCD patients. In addition, the investigators hypothesize that combined CXCR4 and VLA-4 blockade with motixafortide plus natalizumab will result in a rapid, robust, and synergistic increase in HSC mobilization to peripheral blood (PB) in patients with SCD, when compared to motixafortide alone.
Interventions
- PROCEDURE Leukapheresis
- DRUG Motixafortide
- DRUG Natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-07-07 |
| Est. Completion | 2025-06-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05618301
The ClinicalTrials.gov registry entry for NCT05618301 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leukapheresis is the first listed.
NCT05618301 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05618301 about?
NCT05618301 is a clinical study titled "Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)". Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate ...
What is the current status of trial NCT05618301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-07-07. Estimated completion is 2025-06-24.
What interventions are being tested in trial NCT05618301?
The interventions under investigation include: Leukapheresis (PROCEDURE), Motixafortide (DRUG), Natalizumab (DRUG).
Who is sponsoring clinical trial NCT05618301?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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