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FT839 in Autoimmune Diseases

RecruitingPhase 1, Phase 2

Sponsor: Fate Therapeutics

Conditions: ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)

Interventions: FT839

Countries: United States

The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥18 to ≤70 years
* Must have active B-cell mediated autoimmune disease (AAV, IIM, RA, SLE, or SSc) confirmed by standard criteria
* Moderate to severe disease, requiring at least two prior treatments that were ineffective
* Adequate organ function to tolerate treatment
* Able to provide informed consent and comply with study procedures

Exclusion Criteria:

* Diagnosis of more than 1 disease under study (AAV, IIM, RA, SSc, or SLE) or overlap syndrome
* Women must not be pregnant or nursing
* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
* Active or chronic infections
* Active or recent malignancies
* Prior CAR T-cell therapy or organ transplantation
* Known allergies to study treatments
* Body weight \<45 kg
* Active central nervous system (CNS) symptoms attributable to autoimmune disease or nonmalignant CNS disease within 12 months prior to trial intervention
* Receipt of any anti-CD19- or anti-CD20-directed therapy within 6 months prior to trial intervention

Locations (1)

Fullerton, California, United States