FT819 in B-cell Mediated Autoimmune Diseases
Research type
Research Study
Full title
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases
IRAS ID
1009896
Contact name
Shannon Rosemark
Contact email
Sponsor organisation
Fate Therapeutics, Inc.
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
People diagnosed with antineutrophilic cytoplasmic antibody associated vasculitis (also called AAV), idiopathic inflammatory myositis (also called IIM), systemic lupus erythematosus (also called SLE), or systemic sclerosis (also called SSc), which are autoimmune diseases that have not responded to standard treatment, are being invited to take part in this study.
This study is testing an investigational medicinal product (IMP) called FT819. FT819 is produced from cells that came from a healthy human donor. The donor cells are put through a manufacturing process that enables them to generate FT819 T cells. FT819 is made up of “T cells” which are a type of blood cell that is part of the immune system, which helps the body fight off infections
Participants will first enter a screening period. If eligible, participants will be placed into a treatment group and receive either 1 or 2 doses of FT819, with or without non-investigational drug(s). Depending on the group to which they are assigned, participants may continue a stable dose of their current disease medication.
The study cycle is expected to last about 30 days. During the study cycle, participants will have appointments at the study site (8-10 visits total) for study tests and procedures. Depending on the initial response to FT819, some participants may have up to two cycles of treatment.
Participants will be admitted to the hospital for 3 days after the administration of each FT819 dose.
Tests and procedures will include receiving the study drugs, having blood drawn, and checking to see how they are responding to the study drugs and any side effects they may have.
Participants will continue to have visits for up to 2 years after the last dose of FT819 and may be contacted on a regular basis for up to 15 years.
Up to 244 participants will be enrolled globally.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0103
Date of REC Opinion
6 Aug 2025
REC opinion
Further Information Favourable Opinion