Actively Recruiting
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.
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
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.
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
CONTACT
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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