FT819 for Lupus

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Fate Therapeutics

Must not be taking: CNS medications

Disqualifiers: Neurological symptoms, Irreversible organ damage, others

No Placebo Group

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). 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.

Research Team

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.

See 2 more

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.

See 1 more

Trial 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 (CAR T-cell Therapy)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: FT819Experimental Treatment4 Interventions

Participants with moderate to severe active SLE.