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NCT03653247 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by Sangamo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 5
- Study locations
NCT03653247 is a Phase 1 study of Sickle Cell Disease that has completed, run by Sangamo Therapeutics. The registered enrollment target is 7 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT03653247, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by Sangamo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.
Conditions Studied
Interventions
- DRUG Busulfan
- BIOLOGICAL Plerixafor
- GENETIC BIVV003
Study Locations (5)
California
- UCSF Benioff Children's Hospital - Oakland
- University of California Davis Comprehensive Cancer Center - Sacramento
Georgia
- Children's Healthcare of Atlanta - Atlanta
Maryland
- Investigational Site Number 101 - Bethesda
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-03-06 |
| Est. Completion | 2025-07-17 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03653247
The ClinicalTrials.gov registry entry for NCT03653247 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 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 (98% lower). The listed sponsor is Sangamo Therapeutics, which has 25 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 3 interventions - of which Busulfan is the first listed.
NCT03653247 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, Georgia, Maryland.
Frequently Asked Questions
What is clinical trial NCT03653247 about?
NCT03653247 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease". This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.
What is the current status of trial NCT03653247?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-03-06. Estimated completion is 2025-07-17.
What conditions does trial NCT03653247 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT03653247?
The interventions under investigation include: Busulfan (DRUG), Plerixafor (BIOLOGICAL), BIVV003 (GENETIC).
Who is sponsoring clinical trial NCT03653247?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03653247 being conducted?
This trial has 5 study locations across California, Georgia, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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