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

ClinicalTrials.gov ID: NCT07085104

Public ClinicalTrials.gov record NCT07085104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 12:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT07085104
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Allogene Therapeutics; Industry
Enrollment: 66 participants

Conditions and interventions

Conditions

Interventions

Genetic · Drug

Eligibility (public fields only)

Age range: 18 Years to 74 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 12, 2025
Primary completion: Jan 31, 2028
Completion: Sep 30, 2032
Last update posted: Jul 30, 2026

2025 – 2032

United States locations

U.S. sites: 14
U.S. states: 13
U.S. cities: 14

Facility	City	State	ZIP	Site status
Mayo Clinic	Phoenix	Arizona	85054	Recruiting
Loma Linda University Medical Center	Loma Linda	California	92354	Recruiting
University of Colorado Denver	Aurora	Colorado	80045	Recruiting
Mayo Clinic	Jacksonville	Florida	32224	Recruiting
The University of Chicago Medical Center	Chicago	Illinois	60637	Recruiting
University of Iowa	Iowa City	Iowa	52242	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	66160	Recruiting
Norton Cancer Institute, St. Matthews Campus	Louisville	Kentucky	40207	Recruiting
Astera Cancer Care	East Brunswick	New Jersey	08816	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Recruiting
Duke University Medical Center	Durham	North Carolina	27710	Recruiting
Medical University of South Carolina	Charleston	South Carolina	29605	Recruiting
Prisma Health	Greenville	South Carolina	29425	Recruiting
LDS Hospital - lntermountain Health	Salt Lake City	Utah	84143	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07085104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 30, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07085104 live on ClinicalTrials.gov.

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