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

ClinicalTrials.gov ID: NCT06308978

Public ClinicalTrials.gov record NCT06308978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 12:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06308978
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Fate Therapeutics; Industry
Enrollment: 244 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 12 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 28, 2024 (Actual)
Primary completion: Sep 30, 2027 (Estimated)
Completion: Sep 30, 2042 (Estimated)
Last update posted: May 22, 2026

2024 – 2042

United States locations

U.S. sites: 16
U.S. states: 11
U.S. cities: 16

Facility	City	State	ZIP	Site status
Wallace Rheumatic Center	Beverly Hills	California	90210	Recruiting
Providence Medical Foundation	Fullerton	California	92835	Recruiting
University of California Irvine	Irvine	California	92868	Recruiting
Children's Hospital Los Angeles Division Of Rheumatology	Los Angeles	California	90027	Recruiting
University of California San Francisco	San Francisco	California	94110	Recruiting
University of Florida	Gainesville	Florida	32610	Recruiting
Nicklaus Children's Hospital	Miami	Florida	33155	Recruiting
University of Louisville	Louisville	Kentucky	40202	Recruiting
University of Minnesota Medical School	Minneapolis	Minnesota	55455	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	68198	Recruiting
Montefiore Medical Center	New York	New York	10467	Recruiting
Duke University Health System	Durham	North Carolina	27705	Recruiting
MetroHealth	Cleveland	Ohio	44109	Recruiting
University of Oklahoma	Oklahoma City	Oklahoma	73019	Recruiting
Jefferson Einstein Hospital Philadelphia	Philadelphia	Pennsylvania	19141	Recruiting
Regional One Health	Memphis	Tennessee	38103	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06308978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 22, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06308978 live on ClinicalTrials.gov.

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