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FT819 in Moderate to Severe Active Systemic Lupus Erythematosus

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Contents

clinicaltrials.gov/study/NCT06308978
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT063089780
Health Conditions in Trial
Systemic lupus erythematosus
Systemic lupus erythematosus
0
Trial Recruitment Size
320
Trial Sponsor
Fate Therapeutics
Fate Therapeutics
0
Clinical Trial Start Date
February 24, 2024
0
Primary Completion Date
September 30, 2027
0
Study Completion Date
September 30, 2042
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 10
Participating Facility
University of Nebraska Medical Center
University of Nebraska Medical Center
0
‌
University of Minnesota Medical School
0
Official Name
A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus0
Last Updated
March 13, 2024
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Fludarabine0
FT8190
Cyclophosphamide0
Bendamustine0
Study summary

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

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