Summary

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.

Age: 12 Years to 70 Years old

Gender: All

Start Date: 03/28/2024

Primary Completion Date (Estimated): 09/30/2027

Study Completion Date (Estimated): 09/30/2042

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 12 Years to 70 Years old

Gender: All

Accepts Healthy Volunteers: No

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).