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FT819 in Moderate to Severe Active Systemic Lupus Erythematosus

Study Purpose

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). 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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female adults ≥18 years and <40 years of age at the time of signing the informed consent form (ICF).
  • - Diagnosed with SLE by the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria.
  • - Positivity for antinuclear antibody, anti-ds-DNA antibody, and/or anti-Smith antibody at screening.
  • - Active SLE at screening, as defined by SLEDAI ≥8 points (with a clinical SLEDAI ≥4 points, excluding alopecia, mucosal ulcers, and fever); AND one or more major organ systems with British Isles Lupus Assessment Group (BILAG) A score, excluding musculoskeletal, mucocutaneous, and/or constitutional organ systems.
  • - Failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.

Exclusion Criteria:

  • - Active neurological symptoms of SLE at screening.
  • - Potentially irreversible organ damage related to SLE, where in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant.
  • - Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment.
  • - Prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant.

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.

 Systemic Lupus Erythematosus
Arms & Interventions

Arms

Experimental: FT819

Participants with moderate to severe active SLE.

Interventions

Drug: - FT819

FT819 will be administered as a single-dose 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 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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