Home › Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis › NCT06308978

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

RecruitingPhase 1

Who can join

Ages 12 to 70 · All sexes

Full eligibility criteria

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).

About the study

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) with or without nephritis, 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.

What is being tested

FT819 (drug)
Fludarabine (drug)
Cyclophosphamide (drug)
Bendamustine (drug)

Sponsor: Fate Therapeutics · Participants: 244 · Started: Mar 28, 2024

Contact the study team

Fate Clinical Trials · Phone: 858-875-1800

Official record on ClinicalTrials.gov — NCT06308978

Locations in the U.S.

California	Wallace Rheumatic Center, Beverly Hills Providence Medical Foundation, Fullerton University of California Irvine, Irvine Children's Hospital Los Angeles Division Of Rheumatology, Los Angeles University of California San Francisco, San Francisco
Florida	University of Florida, Gainesville Nicklaus Children's Hospital, Miami
Kentucky	University of Louisville, Louisville
Minnesota	University of Minnesota Medical School, Minneapolis
Nebraska	University of Nebraska Medical Center, Omaha
New York	Montefiore Medical Center, New York
North Carolina	Duke University Health System, Durham
Ohio	MetroHealth, Cleveland
Oklahoma	University of Oklahoma, Oklahoma City
Pennsylvania	Jefferson Einstein Hospital Philadelphia, Philadelphia
Tennessee	Regional One Health, Memphis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.