NCT07800871 FT839 in Autoimmune Diseases
| NCT ID | NCT07800871 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fate Therapeutics |
| Condition | ANCA-Associated Vasculitis (AAV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 446 participants |
| Start Date | 2026-10 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 446 participants in total. It began in 2026-10 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07800871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying ANCA-Associated Vasculitis (AAV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07800871 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07800871 currently recruiting?
Yes, NCT07800871 is actively recruiting participants. Contact the research team at clinicaltrials@fatetherapeutics.com for enrollment information.
Where is the NCT07800871 trial being conducted?
This trial is being conducted at Fullerton, United States.
Who is sponsoring the NCT07800871 clinical trial?
NCT07800871 is sponsored by Fate Therapeutics. The trial plans to enroll 446 participants.