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A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Sponsor: Allogene Therapeutics
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).
Official title: A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-11-13
Completion Date
2032-10
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
ALLO-329
An allogeneic CAR T cell therapy targeting CD19 and CD70
Cyclophosphamide
Chemotherapy for lymphodepletion
Locations (13)
Mayo Clinic
Phoenix, Arizona, United States
University of Colorado Denver
Aurora, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
LDS Hospital - lntermountain Health
Salt Lake City, Utah, United States
Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada