Clinical trial for ANCA-Associated Vasculitis (AAV)
Official title FT839 in Autoimmune Diseases
ClinicalTrials.gov ID: NCT07800871
What this study is testing
What is FT839?
FT839 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anca-associated vasculitis (aav).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.