Clinical trial • Phase I • Immunology
FT819 for B-cell mediated autoimmune diseases
Phase I trial of FT819 for B-cell mediated autoimmune diseases. 194 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- B-cell mediated autoimmune diseases
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-04-2025
- First CTIS Authorization Date
- 30-09-2025
Trial design
Phase I trial across 3 sites in Sweden, France.
- Target Sample Size
- 194
Eligibility
Recruits 194 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Recruitment
- Planned Sample Size
- 194
- Recruitment Window Months
- 206
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 50
Sweden
- Earliest CTIS Part Ii Submission Date
- 20-06-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 171
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Clinical Research and Development Unit,KFUE Dep.Of Oncology,Hematology and Endocrine CancersEntrance
- Principal Investigator Name
- Dag Leonard
- Principal Investigator Email
- dag.leonard@medsci.uu.se
- Contact Person Name
- Dag Leonard
- Contact Person Email
- dag.leonard@medsci.uu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Clinical Trials Unit, Rheumatology Department, ME Gastro Hud Reuma
- Principal Investigator Name
- Katerina Chatzidionysiou
- Principal Investigator Email
- aikaterini.chatzidionysiou@ki.se
- Contact Person Name
- Katerina Chatzidionysiou
- Contact Person Email
- aikaterini.chatzidionysiou@ki.se
France
- Earliest CTIS Part Ii Submission Date
- 24-07-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 127
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Médecine Interne
- Principal Investigator Name
- Micheline Pha
- Principal Investigator Email
- micheline.pha@aphp.fr
- Contact Person Name
- Micheline Pha
- Contact Person Email
- micheline.pha@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Fate Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- FT819
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