Evaluating FT819 for autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study aims to assess the safety, pharmacokinetics, and anti-B-cell activity of FT819 in patients with moderate to severe active autoimmune diseases, including systemic lupus erythematosus, ANCA-associated vasculitis, idiopathic inflammatory myositis, and systemic sclerosis. The study will involve a dose-escalation phase followed by an expansion phase to further evaluate the treatment's safety and efficacy. Participants will receive FT819, with or without auxiliary medicinal products, to determine the optimal dosing and therapeutic effects.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age: 12 to 70 years old.
* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
* Health Status: Adequate organ function to tolerate treatment.
* Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.

Key Exclusion Criteria:

* Pregnancy/Breastfeeding: Women must not be pregnant or nursing.
* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
* Active Infections: No recent or ongoing serious infections.
* Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
* Allergies: No known allergies to study treatments.
* Weight Restriction: Must weigh at least 50 kg (110 lbs).

Where it's running

• Wallace Rheumatic Center
  Beverly Hills, California, United States Recruiting
• Providence Medical Foundation
  Fullerton, California, United States Recruiting
• University of California Irvine
  Irvine, California, United States Recruiting
• Children's Hospital Los Angeles Division Of Rheumatology
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Study coordinator: Fate Clinical Trials
• Email: clinicaltrials@fatetherapeutics.com
• Phone: 858-875-1800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.