Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07085104
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

GENETIC

ALLO-329

An allogeneic CAR T cell therapy targeting CD19 and CD70

DRUG

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