A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Start Date
11/13/2025
Completion Date
10/1/2032
Summary
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
Eligibility Criteria
Age Range: 18 years to 74 years
Interventions
ALLO-329
Cyclophosphamide
Fludarabine
Conditions
Locations
Mayo Clinic
Phoenix, Arizona 85054
United States
Loma Linda University Medical Center
Loma Linda, California 92354
United States
University of Colorado Denver
Aurora, Colorado 80045
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
The University of Chicago Medical Center
Chicago, Illinois 60637
United States
University of Iowa
Iowa City, Iowa 52242
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky 40207
United States
Johns Hopkins Hospital
Baltimore, Maryland 21224
United States
Astera Cancer Care
East Brunswick, New Jersey 08816
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Atrium Health Rheumatology-Southpark
Charlotte, North Carolina 28211
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Medical University of South Carolina
Charleston, South Carolina 29605
United States
Prisma Health
Greenville, South Carolina 29425
United States
LDS Hospital - lntermountain Health
Salt Lake City, Utah 84143
United States
Hôpital Maisonneuve Rosemont
Montreal, Quebec H1T 2M4
Canada