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.
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
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
Single group
FT839
Biological/VaccineSingle Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4
8
Treatment groupsSee each treatment group below.
Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events
Incidence and severity of dose-limiting Toxicity (DLT)s, adverse event (AE)s, and serious adverse event (SAE)s
Phase 2: Change from baseline in Birmingham Vasculitis Activity Score
Birmingham Vasculitis Activity Score (BVAS) will be measured to evaluate the efficacy of FT839 in AAV. The BVAS score ranges from 0 to 63, with lower scores indicating better outcomes.
Phase 2: Change from baseline in Manual muscle testing-8
Manual muscle testing-8 (MMT-8) will be measured to evaluate the efficacy of FT839 in IIM. The MMT-8 score ranges from 0 to 150, with higher scores indicating better outcomes.
Phase 2: Change from baseline in Disease Activity Score using 28 joint counts and C-reactive protein (a composite measure)
Disease Activity Score using 28 joint counts and C-reactive protein (DAS28-CRP) will be measured to evaluate the efficacy of FT839 in RA. The validated composite measure DAS28-CRP score ranges from 0.0 to 9.4, with lower scores indicating better outcomes.
Phase 1: Maximum concentration and area under the curve of FT839 in peripheral blood
Pharmacokinetics (PK) of FT839 in peripheral blood including but not limited to maximum concentration (Cmax) and area under the curve (AUC) will be estimated based on observed plasma concentration-time data.
Phase 2: Incidence of AEs and SAEs
Incidence and severity of AEs and SAEs
Phase 2: Cmax of FT839 in peripheral blood
PK of FT839 in peripheral blood including but not limited to Cmax will be estimated based on observed plasma concentration-time data
Phase 2: AUC of FT839 in peripheral blood
PK of FT839 in peripheral blood including AUC will be estimated based on observed plasma concentration-time data
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