StudyFinder
MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune DIseases
Status: 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.
Sex: Male or Female
Age Group: 18 years and over
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
Interventions:
Drug: Bendamustine, Drug: Cyclophosphamide, Drug: FT819, Drug: Fludarabine
Conditions:
Immune Diseases
Keywords:
Clinics and Surgery Center (CSC), SLE, Systemic Lupus Erythematosus
Study Contact: Parastoo Fazeli - pfazeli@umn.edu
Principal Investigator: Parastoo Fazeli
Phase: PHASE1
IRB Number: STUDY00020865
See this study on ClinicalTrials.gov