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RecruitingPhase 1 / Phase 2

FT839 in Autoimmune Diseases

An Open-Label, Multicenter, Phase 1/2 Dose-Escalation and Expansion Trial Evaluating the Safety and Efficacy of FT839 in Participants With Autoimmune Diseases

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 15 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of FT839, given alone or with rituximab or other treatments. It aims to find the highest dose people can tolerate or a dose for the next study phase. It is for adults ages 18 to 70 with certain autoimmune diseases, where the immune system attacks the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 70 years old.
  • You have a confirmed, active autoimmune disease involving immune cells called B cells: AAV (blood vessel inflammation), IIM (muscle inflammation), RA (rheumatoid arthritis), SLE (lupus), or SSc (systemic sclerosis, which hardens skin and may affect organs).
  • Your disease is moderate to severe, and at least two past treatments did not work.
  • Your organs work well enough to handle treatment.
  • You can give informed consent, meaning you understand and agree to join, and can follow study steps.

Who can't join

  • You have more than one of the diseases being studied, or an overlap syndrome with features of several diseases.
  • You are pregnant or breastfeeding.
  • You have serious heart, lung, liver, or kidney problems.
  • You have an active or long-lasting infection, or current or recent cancer.
  • You have had CAR T-cell therapy (treatment using changed immune cells) or an organ transplant.
  • You have a known allergy to a study treatment, or weigh less than 45 kg (about 99 pounds).
  • You have active brain or spinal cord symptoms caused by autoimmune disease, or had a noncancerous brain or spinal cord disease within 12 months before study treatment.
  • You received treatment targeting CD19 or CD20 (markers on certain immune cells) within 6 months before study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA