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SCD Stem Cell Mobilization and Apheresis Using Motixafortide

StatusRecruiting
PhasePhase 1
Started2024-11-14
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
Study Status, Study Design, Eligibility v13
Enrollment increased: 15 → 20 participants
Eligibility criteria+1 characters
[...] quate. ECOG performance status/Karnofsky score/Lansky score >≥ 80 White blood cell (WBC) count >3.0 x 10^9/L, absolute neut [...]
2026-06-02
Study Status, Contacts/Locations v12
Study sites2→3
2026-04-22
Study Status, Study Description, Contacts/Locations v11
Study descriptionrevised
[...] drug, motixafortide, by an injection under the skin. About 48 hours after the injection, stem cells will be collected. Pa [...]
Study sitescontacts updated at 1 of 2 sites
2026-01-28
Study Status, Sponsor/Collaborators, Study Description v10
Study descriptionrevised
[...] drug, motixafortide, by an injection under the skin. About 84 hours after the injection, stem cells will be collected. Pa [...]
Collaborators1 entry, revised
BioLineRx,Ayrmid Ltd.
2025-12-11
Study Status, Contacts/Locations v9
Study sites1→2
Show 8 earlier versions
2025-09-02
Study Status, Study Description, Eligibility, Contacts/Locations v8
Primary completion date2026-01→2028-01
Completion date2026-07→2028-07
Eligibility criteria-41 characters
[...] tory Participants should either have a central line in place or, be able to undergo apheresis without the necessity of the insertion of a central venous catheter, or agree to have a central line placed if IV access is inadequate. ECOG performance status/Karnofsky score/Lansky score >80 Wh [...] monary status (i.e., no evidence of pulmonary hypertension) within the last 6 months must be sufficient to undergo apheresis, as assessed by the [...] tor or an independent physician evaluating the participant. If an assessment has not been done within the last 6 months, an echocardiogram will be performed. Negative [...] [...]
Study description+108 characters
[...] l collection. Study staff will contact participants about 30 (±3) days after the last drug dose administration. The follow up may be conducted in person if the participant is in clinic during that follow up period.
Study sitescontacts updated at 1 of 1 site
2025-05-07
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2024-12-16
Study Status, Eligibility v6
Start dateestimated 2024-12→confirmed 2024-11-14
Eligibility criteria-1 characters
[...] ndergo apheresis, as assessed by the Principal Investigator andor an independent physician evaluating the participant. Negati [...]
2024-11-07
Study Status v5
Start date2024-11→2024-12
2024-10-10
Study Status v4
Start date2024-10→2024-11
2024-09-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2024-09→2024-10
Study sitesdetails revised at 1 of 1 site
2024-08-02
Study Status v2
Start date2024-07→2024-09
2024-06-13
Study Identification, Study Status v1
Start date2024-06→2024-07
Study title-1 characters
SCD Stem Cell Mobilization and Apheresis Using MotiixafortideMotixafortide
2024-05-29
Original filing
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
Trial Details
NCT Number NCT06442761
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: Ayrmid Ltd
Conditions Sickle Cell Disease
Enrollment 20 participants
Start Date 2024-11-14
Primary Completion 2028-01 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-08