FT839: Single Intravenous (IV) infusion of FT839 administered on Day 1 and Day 4
Study summary
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Phase 1: Incidence of Dose-limiting Toxicity, Adverse Events, and Serious Adverse Events — From enrollment to the end of the post-treatment follow-up at 2 years 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 — From enrollment to the end of the post-treatment follow-up at 2 years 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 — From enrollment to the end of the post-treatment follow-up at 2 years 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) — From enrollment to the end of the post-treatment follow-up at 2 years 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 2: Change from baseline in SLE Disease Activity Index 2000 — From enrollment to the end of the post-treatment follow-up at 2 years SLE Disease Activity Index 2000 (SLEDAI-2K) score will be measured to evaluate the efficacy of FT839 in SLE. The SLEDAI-2K score ranges from 0 to 105, with lower scores indicating better outcomes.
Phase 2: Change from baseline in Modified Rodnan skin score — From enrollment to the end of the post-treatment follow-up at 2 years Modified Rodnan skin (mRSS) score will be measured to evaluate the efficacy of FT839 in SSc. The mRSS score ranges from 0 to 51, with lower scores indicating better outcomes.
Trial sites (1)
Facility
City
Region
Status
Providence Medical Foundation
Fullerton
California
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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