Trial · NCT05618301
Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)
NCT05618301, Phase 1, Completed, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD). Trials, record NCT05618301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05618301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)
- NCT number
- NCT05618301
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Sickle Cell Disease
- Interventions
- Motixafortide, Natalizumab, Leukapheresis
- First posted
- 2022-11-16
- Last updated
- 2025-08-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability as assessed by the incidence of dose-limiting toxicities (DLTs) | Through 28 days following administration of either motixafortide and/or natalizumab (estimated to be 8 weeks and 4 days) | * All toxicities will be graded using NCI-CTCAE Version 5.0 * A DLT is an event occurring during the DLT period of 28 days following administration of either motixafortide and/or natalizumab that is considered to be at least possibly, probably or definitely related to study treatment by the investigator, and that meets the criteria below: * Hematologic criteria * Any Grade 5 adverse event * Any Grade 4 adverse event, excluding Grade 4 hemolysis, bilirubin increase, leukocytosis, erythrocytosis, thrombocytosis, anemia, leukopenia, or febrile neutropenia * Non-hematologic criteria * Any Grade 4 or 5 adverse event. * Any Grade 3 or higher arterial or venous thromboembolic event * Any Grade 2 or 3 adverse event that does not resolve within 4 weeks; with the exception of \<grade 2 injection site reactions. |
| Secondary | Number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis per liter (L) of total volume (tV) processed following motixafortide alone and motixafortide + natalizumab | Day 2 and Day 60 | |
| Secondary | Number of CD34+ hematopoietic stem and progenitor cells (HSPCs) mobilized via leukapheresis per liter (L) of adjusted volume (aV) processed, following motixafortide alone and motixafortide + natalizumab | Day 2 and Day 60 | -The adjusted volume will be calculated as the total volume (tV) processed minus the volumes processed to establish/re-establish the HSC collection interface (iV) to yield an adjusted volume (aV) (i.e. tV-iV=aV). The number of apheresis alarms along with the amount of time, flow rate and volumes processed to establish the interface will be recorded during apheresis and entered into the eCRF. Use of aV will control for the effect of any apheresis alarms; which pause the centrifuge leading to loss of the collection interface. |
| Secondary | Change in kinetics of CD34+ HSC mobilization in response to motixafortide alone and motixafortide + natalizumab in SCD patients, as assessed by CD34+ cells/ul in peripheral blood | From baseline through Day 60 | |
| Secondary | Frequency of adverse events | From start of treatment through 8 weeks following completion of all treatment (estimated to be 16 weeks and 4 days) | -All adverse events will be graded using NCI-CTCAE Version 5.0 |
| Secondary | Change in peak CD34+ HSC mobilization in response to motixafortide alone and motixafortide + natalizumab in SCD patients, as assessed by CD34+ cells/ul in peripheral blood | From baseline through Day 60 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05618301
GET https://conductscience.org/api/trials/v1/NCT05618301/registered