Actively Recruiting
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
Led by Allogene Therapeutics · Updated on 2026-04-07
66
Participants Needed
13
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ALLO-329, an allogeneic CAR T cell therapy targeting CD19 and CD70, in adults with autoimmune diseases including systemic lupus erythematosus (SLE) with and without kidney involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc). This first-in-human, open-label, single-arm study aims to assess the safety, tolerability, and initial biological activity of ALLO-329 and to establish the recommended dosing regimen for future studies. Participants receive ALLO-329 either after a lymphodepletion treatment with cyclophosphamide or without the lymphodepletion regimen. The study compares these two approaches to determine safety and clinical response. ALLO-329 is a genetic therapy designed to target specific disease-related immune cells, and the trial will closely monitor its effects over time. During the study, participants will undergo regular visits for safety assessments, including monitoring for dose-limiting toxicities up to 60 months. Researchers will also evaluate disease response in SLE, lupus nephritis, IIM, and SSc using clinical and laboratory tests. The study tracks ALLO-329's presence and activity in the body, ensuring ongoing safety and effectiveness monitoring throughout the long-term follow-up period.
CONDITIONS
Brief Title
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to under 70 years
- Adequate blood, liver, heart, and lung function
- Negative pregnancy test for females of childbearing potential
- Willing to use effective contraception for 12 months (females) or 6 months (males) after treatment
- Signed informed consent
- Ability to follow study visits and procedures
- Confirmed active systemic lupus erythematosus, idiopathic inflammatory myopathy, or systemic sclerosis
- Disease active despite prior standard treatment including at least one immunosuppressive agent for 3 months
You will not qualify if you...
- Active bacterial, fungal, or viral infection requiring systemic treatment
- Active cancer within 5 years except certain treated skin cancers and low risk prostate cancer
- Previous treatment with CD19 or CD70 targeted therapy or any engineered cell therapy
- Unstable or uncontrolled diseases not due to autoimmune conditions
- Recent symptomatic heart or vascular disease or significant ECG abnormalities
- Moderate to severe liver cirrhosis (Child-Pugh Class B or C)
- Symptomatic airway disease requiring treatment or recent pulmonary embolism
- Refractory to blood transfusions or refusal of transfusion support
- Primary inherited immunodeficiency
- Unwillingness to participate in extended safety monitoring
- Active CNS involvement or drug-induced lupus within 6 months for SLE
- Recent dialysis or severe kidney damage for lupus nephritis
- Other specific exclusions for IIM and SSc including severe symptoms and antibody status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants receive ALLO-329, an allogeneic CAR T cell therapy targeting CD19 and CD70. Some participants receive a lymphodepletion regimen with cyclophosphamide before ALLO-329.
Visits scheduled throughout treatment period to monitor safety and efficacy
Duration - Up to 60 months
Participants continue safety and efficacy monitoring after treatment completion to assess long-term outcomes.
Regular follow-up visits during the post-treatment period
Trial Site Locations
Total: 13 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
Actively Recruiting
7
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29605
Actively Recruiting
11
Prisma Health
Greenville, South Carolina, United States, 29425
Actively Recruiting
12
LDS Hospital - lntermountain Health
Salt Lake City, Utah, United States, 84143
Actively Recruiting
13
Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
Research Team
A
Allogene Therapeutics, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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