Actively Recruiting
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Led by Allogene Therapeutics · Updated on 2026-04-07
66
Participants Needed
13
Research Sites
359 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 less than 70 years
- Adequate blood, liver, heart, and lung function
- Negative pregnancy test for females of childbearing potential
- Willingness to use effective contraception for 12 months (females) or 6 months (males) after treatment
- Signed informed consent
- Ability to follow study visits, treatments, and tests
- Confirmed active SLE, IIM, or SSc by clinical or laboratory criteria
- Active disease despite prior standard immunosuppressive treatment for at least 3 months (plus hydroxychloroquine)
You will not qualify if you...
- Active systemic bacterial, fungal, or viral infection needing treatment
- Any active cancer within 5 years except certain treated skin or low-risk prostate cancers
- Previous treatment with CD19 or CD70 targeted therapy or engineered cell therapy
- Unstable or uncontrolled acute or chronic diseases not related to SLE, IIM, or SSc
- Symptomatic heart or vascular disease needing intervention within 6 months
- Child-Pugh Class B or C liver cirrhosis
- Symptomatic lung disease requiring treatment, significant pleural effusion, or recent pulmonary embolism
- Known resistance or refusal of transfusions to manage blood counts
- Primary inherited immunodeficiency
- Unwillingness to participate in long-term safety monitoring
- For SLE: active central nervous system disease recently or drug-induced lupus; certain kidney disease severity or dialysis history
- For IIM: non-IIM myositis, irreversible or unrelated weakness, or dermatomyositis with anti-TIF1 gamma antibody
- For SSc: pulmonary arterial hypertension requiring treatment, severe gastrointestinal involvement, or prior kidney crisis related to scleroderma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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