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

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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