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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

NCT07085104 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-07

No results posted yet for this study

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).

Conditions

  • Systemic Lupus Erythematosus (With and Without Nephritis)
  • Idiopathic Inflammatory Myopathy
  • Systemic Sclerosis

Interventions

GENETIC

ALLO-329

An allogeneic CAR T cell therapy targeting CD19 and CD70

DRUG

Cyclophosphamide

Chemotherapy for lymphodepletion

Sponsors & Collaborators

  • Allogene Therapeutics

    lead INDUSTRY

Principal Investigators

  • Allogene Study Director · Allogene Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2028-02-29
Completion
2032-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085104 on ClinicalTrials.gov