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MT2023-42: A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Recruiting

This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• 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
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant

Drug: Bendamustine, Drug: Cyclophosphamide, Drug: FT819, Drug: Fludarabine

Immune Diseases

Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus

Parastoo Fazeli - pfazeli@umn.edu
Parastoo Fazeli
PHASE1
STUDY00020865
See this study on ClinicalTrials.gov

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