FT819 for Lupus

Recruiting at 3 trial locations

Overseen By Fate Trial Disclosure

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Fate Therapeutics

Must not be taking: CNS medications

Disqualifiers: Neurological symptoms, Irreversible organ damage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

244 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate to severe active systemic lupus erythematosus (SLE), antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants must have failed to respond to certain treatments, which suggests you might need to continue some existing medications. Please consult with the trial coordinators for specific guidance.

Eligibility Criteria

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.

Inclusion Criteria

My blood test shows positive for specific autoimmune antibodies.

I am between 18 and 40 years old.

My condition did not improve after using steroids and at least two other specific treatments for 3 months.

Exclusion Criteria

My lupus has caused severe organ damage that likely won't improve with CD19 CAR T-cell therapy.

I am experiencing neurological symptoms due to lupus.

I have had CAR T-cell therapy, an organ transplant, or a stem cell transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of FT819 to evaluate safety and determine the recommended Phase 2 dose

4 weeks

Expansion

Further evaluation of the safety and activity of FT819 in a larger group of participants

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FT819

Trial Overview 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.

Participant Groups

Group I: Regimen D (Two-dose without AMP, with background therapy) Experimental Treatment 1 Intervention

Group II: Regimen C (Two-dose with AMP) Experimental Treatment 4 Interventions

Group III: Regimen B1 (Single-dose without AMP, background therapy temporarily suspended) Experimental Treatment 1 Intervention

Group IV: Regimen B (Single-dose without AMP, with background therapy) Experimental Treatment 1 Intervention

Group V: Regimen A (Single dose with AMP) Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Fate Therapeutics

Lead Sponsor

Trials

22

Recruited

1,200+