FT839 in Autoimmune Diseases
Recruiting · NCT07800871 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
FT839
What this trial is 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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Providence Medical Foundation - Fullerton, California, United States