Actively Recruiting
Study of AlloNK, a Cord Blood-derived NK Cell Therapy, with Rituximab in Relapsing B-cell Dependent Rheumatologic Diseases Open-label Phase 2a Safety and Efficacy Evaluation
Led by Artiva Biotherapeutics, Inc. · Updated on 2025-12-24
90
Participants Needed
26
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of AlloNK, a non-genetically modified natural killer (NK) cell therapy derived from cord blood, combined with rituximab. This open-label Phase 2a trial focuses on adults with relapsing forms of B-cell dependent rheumatologic diseases, including refractory rheumatoid arthritis, Sj f6gren's disease, idiopathic inflammatory myopathies, and systemic sclerosis. The goal is to evaluate how this combination treatment works in these difficult-to-treat conditions. Participants receive AlloNK following a conditioning regimen along with rituximab. AlloNK is an off-the-shelf, cryopreserved NK cell therapy given to support the immune response. The study does not mention a placebo group, and all participants receive this combination treatment. The trial monitors participants for up to 104 weeks to assess safety and treatment effects. Throughout the study, participants undergo regular assessments including clinical evaluations, laboratory tests, and disease activity measurements specific to their condition. Researchers will monitor safety from enrollment until the end of treatment at week 104. The study aims to better understand the treatment's impact on disease symptoms and progression over this two-year period.
CONDITIONS
Official Title
AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of rheumatoid arthritis meeting 2010 ACR/EULAR criteria with positive Rheumatoid Factor or Anti Citrullinated Protein Antibody
- High-sensitivity C-reactive protein > 3 mg/L or Erythrocyte Sedimentation Rate > 28 mm/hr
- Prior biologic disease modifying anti-rheumatic drug treatment for at least 12 weeks with refractory disease
- At least six swollen and six tender joints on assessment
- Confirmed primary Sj�f6gren's disease diagnosis within 24 weeks before screening per 2016 ACR/EULAR criteria
- European League Against Rheumatism Sjogren's Syndrome Disease Activity Index score above 6
- Salivary flow rate above 0.1 mL/min with stimulation
- Positive autoantibody (ANA >1:80 or RNP or SSA/SSB or other myositis specific autoantibodies) for idiopathic inflammatory myopathies
- Refractory idiopathic inflammatory myopathies with inadequate response or intolerance to at least 3 months of glucocorticoids and/or one other immunosuppressive
- Muscle biopsy or muscle MRI confirming diagnosis within 12 months before enrollment
- Systemic sclerosis diagnosis per ACR/EULAR 2013 classification with skin score above 10
- Confirmed systemic sclerosis diagnosis within 8 years before screening
- Refractory systemic sclerosis with inadequate response or intolerance to at least 3 months of glucocorticoids and/or one other immunosuppressive
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Artiva Investigational Site Tuscaloosa
Tuscaloosa, Alabama, United States, 35406
Actively Recruiting
2
Artiva Investigational Site Phoenix
Phoenix, Arizona, United States, 85037
Actively Recruiting
3
Artiva Investigational Site Covina
Covina, California, United States, 91723
Actively Recruiting
4
Artiva Investigational Site Los Alamitos
Los Alamitos, California, United States, 90720
Actively Recruiting
5
Artiva Investigational Site Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
6
Artiva Investigational Site Jupiter
Jupiter, Florida, United States, 33458
Actively Recruiting
7
Artiva Investigational Site Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
8
Artiva Investigational Site Willowbrook
Willowbrook, Illinois, United States, 60527
Actively Recruiting
9
Artiva Investigational Site Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
Artiva Investigational Site Charlotte
Charlotte, North Carolina, United States, 28207
Actively Recruiting
11
Artiva Investigational Site Charlotte
Charlotte, North Carolina, United States, 28625
Actively Recruiting
12
Artiva Investigational Site Hixson
Hixson, Tennessee, United States, 37343
Actively Recruiting
13
Artiva Investigational Site Arlington
Arlington, Texas, United States, 76012
Actively Recruiting
14
Artiva Investigational Site Katy
Katy, Texas, United States, 77494
Actively Recruiting
15
Artiva Investigational Site Mesquite
Mesquite, Texas, United States, 75150
Actively Recruiting
16
Artiva Investigational Site Woodland
Woodland, Texas, United States, 77382
Actively Recruiting
17
Artiva Investigational Site Sofia
Sofia, Bulgaria, 1612
Actively Recruiting
18
Artiva Investigational Site Marseille
Marseille, France, 13005
Actively Recruiting
19
Artiva Investigational Site Montpellier
Montpellier, France, 34090
Actively Recruiting
20
Artiva Investigational Site Toulouse
Toulouse, France, 31059
Actively Recruiting
21
Artiva Investigational Site Munchen
München, Germany, 80336
Actively Recruiting
22
Artiva Investigational Site Brescia
Brescia, Italy, 25125
Actively Recruiting
23
Artiva Investigational Site Vila Nova De Gaia
Vila Nova de Gaia, Portugal, 4434
Actively Recruiting
24
Artiva Investigational Site Bucuresti
Bucharest, Romania, 20125
Actively Recruiting
25
Artiva Investigational Site Bucharest
Bucharest, Romania, 50474
Actively Recruiting
26
Artiva Investigational Site Sevila
Seville, Spain, 41701
Actively Recruiting
Research Team
C
Chanel Mansfield Director, Clinical Operations, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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