RightFit
RecruitingPhase 1

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

Who can join

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

Age
12 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

Not stated in the study description — ask the study team about visits and procedures.

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 early-stage study tests the safety of FT819, how it moves through the body, and how it acts on B cells, a type of immune cell. It is for people ages 12 to 70 with certain moderate-to-severe autoimmune diseases, where the immune system attacks the body. FT819 is tested with or without an added medicine.

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.

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

Eligibility

Who can join

  • Be 12 to 70 years old.
  • Have a confirmed, active disease involving B cells: lupus, ANCA-associated vasculitis (blood vessel swelling), idiopathic inflammatory myositis (muscle swelling), or systemic sclerosis (skin and tissue hardening). Lupus may affect the kidneys or not.
  • Have moderate-to-severe disease, with at least two past treatments that did not work.
  • Have organs that work well enough to handle treatment.
  • Be able to agree to join, or agree with a parent's consent when needed, and follow study steps.

Who can't join

  • Be pregnant or breastfeeding.
  • Have serious heart, lung, liver, or kidney problems.
  • Have a recent or ongoing serious infection.
  • Have current or recent cancer.
  • Have had CAR T-cell therapy, a treatment using changed immune cells, or an organ transplant.
  • Have a known allergy to any study treatment.
  • Weigh less than 50 kg (110 pounds).

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

Official eligibility criteria

Key Inclusion Criteria: * Age: 12 to 70 years old. * Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria. * Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective. * Health Status: Adequate organ function to tolerate treatment. * Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures. Key Exclusion Criteria: * Pregnancy/Breastfeeding: Women must not be pregnant or nursing. * Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment. * Active Infections: No recent or ongoing serious infections. * Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant. * Allergies: No known allergies to study treatments. * Weight Restriction: Must weigh at least 50 kg (110 lbs).

Study sites (16)

CA

FL

KY

MN

NC

NE

NY

OH

OK

PA

TN