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

Study Purpose

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), 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 12 Years - 70 Years
Gender All
More Inclusion & Exclusion 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06308978
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Fate Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
Arms & Interventions

Arms

Experimental: Regimen A (Single dose with AMP)

Experimental: Regimen B (Single-dose without AMP, with background therapy)

Experimental: Regimen C (Two-dose with AMP)

Experimental: Regimen D (Two-dose without AMP, with background therapy)

Experimental: Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)

Interventions

Drug: - FT819

FT819 will be administered as intravenous (IV) infusion at planned dose levels.

Drug: - Fludarabine

Fludarabine will be administered as an IV infusion at planned dose levels.

Drug: - Cyclophosphamide

Cyclophosphamide will be administered as an IV infusion at planned dose levels.

Drug: - Bendamustine

Bendamustine will be administered as an IV infusion at planned dose levels.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California Irvine, Irvine, California

Status

Recruiting

Address

University of California Irvine

Irvine, California, 92868

Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles Division Of Rheumatology

Los Angeles, California, 90027

University of Minnesota Medical School, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota Medical School

Minneapolis, Minnesota, 55455

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

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