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

Launched by FATE THERAPEUTICS · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FT819 for adults with moderate to severe active systemic lupus erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues. The main goals of the study are to see if FT819 is safe and how it works in the body, particularly its ability to target certain immune cells. The trial is in the early stages, and participants will first receive different doses of the treatment to find the most effective amount before moving on to a larger group of participants.

To be part of this trial, participants need to be between 18 and 45 years old and must have been diagnosed with SLE. They should also have certain antibodies in their blood and have active disease despite not responding well to standard treatments. During the study, participants will receive FT819, and doctors will closely monitor their health and any side effects. It's important to note that some individuals, such as those with severe neurological symptoms or certain past treatments, may not be eligible for this study. If you're considering participating, you'll get detailed information about what to expect and the support available throughout the trial.

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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).