← Back to Search

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3770

Bendamustine

2015

Completed Phase 3

~2950

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor

21 Previous Clinical Trials

1,769 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with FT819 in individuals undergoing treatment?

"With the trial being in Phase 1 and having limited safety and efficacy data, FT819 was assigned a safety rating of 1 by our team at Power."

Answered by AI

Is the enrollment for this medical study currently accepting new participants?

"As indicated on clinicaltrials.gov, this study is presently in the recruitment phase. The trial was initially posted on February 24th, 2024 and last modified on March 6th, 2024."

Answered by AI