FT839 in Autoimmune Diseases

Fate Therapeutics

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Rheumatoid Arthritis (RA)

ANCA-Associated Vasculitis (AAV)

Systemic Sclerosis (SSc)

Idiopathic Inflammatory Myositis (IIM)

Systemic Lupus Erythematosus (SLE)

Treatments

Biological: FT839

Study type

Interventional

Funder types

Industry

Identifiers

NCT07800871

FT839-101

Details and patient eligibility

About

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.

Full description

This is a multicenter, Phase 1/2, open-label trial designed to evaluate the safety, pharmacokinetics (PK), anti-B-cell activity, and clinical activity of FT839 in participants with moderate-to-severe ANCA-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc).

Participants will receive FT839 as monotherapy or in combination with rituximab, with or without conditioning therapy and/or stable background therapy. Participants will be enrolled in 2 stages during the Phase 1 portion of the trial: a dose-escalation stage and a dose-expansion stage. In the dose-escalation stage, safety and tolerability will be assessed to define the MTD (or through the maximum assessed dose [MAD] in the absence of dose-limiting toxicities [DLTs] defining the MTD). The DLT evaluation period will extend from Day 1 through Day 29. Participants will be followed during the post-treatment follow-up period for up to 2 years after the first dose of FT839, followed by long-term-follow-up for safety and survival for up to 15 years after the first dose of FT839.

In the dose-expansion stage, participants will be enrolled into disease-specific cohorts to further evaluate the safety and activity of FT839.

Following completion of the Phase 1 portion, the Phase 2 portion of the trial will further evaluate the efficacy of FT839 within each disease cohort.

Enrollment

446 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

446 participants in 8 patient groups

FT839 + Rituximab (Regimen A)

Experimental group

Description: