At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
lovo-celgenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With the LentiGlobin BB305 Lentiviral Vector in Subjects With Severe Sickle Cell Disease
In Brief
A Phase 2 clinical trial evaluating lovo-cel for Sickle Cell Disease. Completed, enrolled 54 participants across 11 sites.
Detailed Summary
This is a non-randomized, open label, multi-site, single dose, Phase 1/2 study in approximately 50 adults and adolescents with severe SCD. The study will evaluate hematopoietic stem cell and progenitor stem cell (collectively referred to as hematopoietic stem and progenitor cells or HSPCs) transplantation using lovo-cel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartFeb 2015
Primary CompletionJul 2023
Study CompletionJan 2024
TodayJul 2026
First PostedMay 16, 2014
Enrollment StartFeb 2, 2015
Primary CompletionJul 31, 2023
Study CompletionJan 30, 2024
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 12.1 years ago
Interventions
lovo-celgenetic
lovo-cel is administered by IV infusion following myeloablative conditioning with busulfan.