drugset / Trial / NCT04541628
Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A
NaSingle-groupOpen-labelTreatment
Summary
SIG-001-121 is a first-in-human (FIH), phase 1/2, multi-centre, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SIG-001 in adults with severe or moderately severe haemophilia A without inhibitors. Up to three dose cohorts (3 patients each) are planned. Cohort expansions (up to 3 additional patients) may be triggered to collect additional information about safety and efficacy.
Timeline
- Start
- 2020-09-28
- Primary completion
- 2022-10-28
- Completion
- 2023-01-09
Outcome
Outcome not reported
Stopped: “SIG-001 programme terminated”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SIG001 | Cell therapy | 50 ml | Other |
| Subject | SIG001 | Cell therapy | 78.5 ml | Other |
| Subject | SIG001 | Cell therapy | 133 ml | Other |