At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
LentiGlobin BB305 Drug Productdrug
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 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the β-Hemoglobinopathies (Sickle Cell Anemia and β-Thalassemia Major) by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a Lentiviral β-A-T87Q Globin Vector (LentiGlobin BB305 Drug Product)
In Brief
A Phase 2 clinical trial evaluating LentiGlobin BB305 Drug Product for Beta-Thalassemia Major and Sickle Cell Disease. Completed, enrolled 7 participants across 1 site.
Detailed Summary
This is a Phase 1/2, open label, safety, and efficacy study of the administration of LentiGlobin BB305 Drug Product to participants with either transfusion dependent beta-thalassemia (TDT) or sickle cell disease (SCD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBeta-Thalassemia Major, Sickle Cell Disease
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedMay 2014
Primary CompletionFeb 2019
TodayJul 2026
First PostedMay 30, 2014
Enrollment StartJun 7, 2013
Primary CompletionFeb 26, 2019
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 12.1 years ago
Interventions
LentiGlobin BB305 Drug Productdrug
LentiGlobin BB305 Drug Product was administered by intravenous (IV) infusion.