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CAR T-cell Therapy

FT819 for Lupus

Phase 1
Recruiting
Research Sponsored by Fate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug, FT819, in participants with moderate to severe lupus. The study will first determine the safety and effects of different doses of the drug, followed by a larger

Who is the study for?
Adults aged 18-40 with moderate to severe active systemic lupus erythematosus (SLE) who haven't responded to standard treatments, including glucocorticoids and other specific medications. Participants must meet certain SLE diagnostic criteria and have active disease as indicated by clinical scores.
What is being tested?
The trial is testing FT819, a new therapy, after conditioning chemotherapy in people with SLE. It includes a dose-escalation stage to find the safe amount of FT819 followed by an expansion stage to further assess its safety and effectiveness against B-cells.
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response such as inflammation or infusion-related symptoms due to FT819 or chemotherapy agents like Bendamustine, Fludarabine, and Cyclophosphamide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with TEAEs by severity
Number of participants with adverse events of special interest (AESI)
Number of participants with dose-limiting toxicities (DLTs)
+3 more
Secondary study objectives
Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time
Change in Physician Global Assessment (PGA) over time
Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FT819Experimental Treatment4 Interventions
Participants with moderate to severe active SLE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Bendamustine
2015
Completed Phase 3
~3230
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,134 Total Patients Enrolled
~43 spots leftby Sep 2027
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