RecruitingPhase 1NCT07085104

A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease

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


Sponsor

Allogene Therapeutics

Enrollment

66 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ALLO-329 and a drug called Cyclophosphamide for people with idiopathic inflammatory myopathy, systemic lupus erythematosus (with and without nephritis), and other related conditions. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years to 69 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICALLO-329

An allogeneic CAR T cell therapy targeting CD19 and CD70

DRUGCyclophosphamide

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

View Full Details on ClinicalTrials.gov

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NCT07085104


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