A Study to Assess the Safety, Tolerability, and Efficacy of ST-400 for Treatment of Transfusion-Dependent Beta-thalassemia (TDT)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Transfusion Dependent Beta-thalassemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Both males and females
Description
Once consented, study participants will progress through the following stages: Screening: in-person visit at the study site to confirm eligibility for proceeding Collection: autologous (self) blood stem cells are harvested at the study site, also known as apheresis Manufacturing of ST-400: no study ...
Once consented, study participants will progress through the following stages: Screening: in-person visit at the study site to confirm eligibility for proceeding Collection: autologous (self) blood stem cells are harvested at the study site, also known as apheresis Manufacturing of ST-400: no study participant activities expected Infusion: conditioning chemotherapy, followed by infusion of ST-400, occurs at the study site Follow-up: follow up at the study site to monitor for safety and effectiveness of the study
Tracking Information
- NCT #
- NCT03432364
- Collaborators
- Sanofi
- Investigators
- Study Director: Medical Monitor Sangamo Therapeutics, Inc.
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