A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
Start Date
3/10/2025
Completion Date
12/31/2031
Summary
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
Detailed Description
This study may enroll up to 80 subjects in total. CTX112 is a CD19 directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of refractory autoimmune diseases. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
CTX112
Conditions
Locations
Stanford University Medical Center
Redwood City, California 94063
United States
Northwestern Medicine, Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois 63110
United States
University of Iowa
Iowa City, Iowa 52242
United States
Manning Family Children's Hospital of New Orleans
New Orleans, Louisiana 70118
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Washington University School of Medicine
St Louis, Missouri 63130
United States
University of North Carolina TraCS Institute - CTRC
Chapel Hill, North Carolina 27599
United States
University of Augsburg
Augsburg, 86156
Germany
Universitätsklinikum Köln
Cologne, 50937
Germany
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
Germany
UCT University Medical Center Mainz
Mainz, 55131
Germany
Research Site 10
Córdoba, 14004
Spain
Research Site 9
Pamplona, 31008
Spain
Research Site 11
Seville, 41013
Spain