Actively Recruiting
An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK4, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases
Led by Artiva Biotherapeutics, Inc. · Updated on 2026-05-22
90
Participants Needed
52
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AlloNK, an allogeneic cord blood-derived natural killer (NK) cell therapy, combined with rituximab for people with relapsing forms of B-cell dependent rheumatologic diseases. These diseases include refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis. This Phase 2a open-label study aims to better understand how this combination therapy works in patients who have not responded well to previous treatments. Participants will receive AlloNK after a conditioning regimen in combination with rituximab. AlloNK is a non-genetically modified, off-the-shelf, cryopreserved NK cell therapy derived from cord blood. The treatment period includes dosing and follow-up to assess safety and response. The study does not involve placebo or blinding, and all participants receive the active combination therapy. During the study, participants will be closely monitored from enrollment through week 104 to assess safety. Disease-specific outcomes will be evaluated at week 52 using different clinical scores depending on the condition: Disease Activity Score 28 (DAS28) for rheumatoid arthritis, Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI) for Sjögren's disease, Total Improvement Score (TIS) for idiopathic inflammatory myopathies, and Revised Composite Response Index in Systemic Sclerosis (rCRISS) for systemic sclerosis. Safety and effectiveness data will be collected through clinical assessments and laboratory tests over the course of the study.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Documented diagnosis of rheumatoid arthritis meeting 2010 ACR/EULAR criteria with positive Rheumatoid Factor or Anti Citrullinated Protein Antibody
- Rheumatoid arthritis patients must have high-sensitivity C-reactive protein > 3 mg/L or erythrocyte sedimentation rate > 28 mm/hr
- Rheumatoid arthritis patients must have had prior biologic disease modifying anti-rheumatic drug treatment for at least 12 weeks and be refractory
- Rheumatoid arthritis patients must have at least six swollen and six tender joint counts
- Prior diagnosis of primary Sjögren's disease confirmed within 24 weeks before screening
- Sjögren's disease patients must have ClinESSDAI score > 6
- Sjögren's disease patients must have salivary flow rate > 0.1 mL/min on stimulation
- Presence of positive autoantibody (ANA >1:80 or RNP or SSA/SSB or other myositis specific autoantibodies) for idiopathic inflammatory myopathies
- Idiopathic inflammatory myopathies patients must be refractory with inadequate response or intolerance to at least 3 months of glucocorticoids or one other immunosuppressive
- Diagnosis of systemic sclerosis per ACR/EULAR 2013 classification
- Systemic sclerosis patients must have modified Rodnan skin score > 10
- Systemic sclerosis diagnosis must be within 8 years of screening
- Systemic sclerosis patients must be refractory to at least 3 months of glucocorticoids 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
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.
Duration - From enrollment until Week 104
Participants receive AlloNK, an allogeneic cord blood-derived NK cell therapy, combined with Rituximab after a conditioning regimen.
Trial Site Locations
Total: 52 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 Tucson
Tucson, Arizona, United States, 85748
Actively Recruiting
4
Artiva Investigational Site Chula Vista
Chula Vista, California, United States, 92108
Actively Recruiting
5
Artiva Investigational Site Covina
Covina, California, United States, 91723
Actively Recruiting
6
Artiva Investigational Site Los Alamitos
Los Alamitos, California, United States, 90720
Actively Recruiting
7
Artiva Investigational Site Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
8
Artiva Investigational Site Santa Ana
Santa Ana, California, United States, 92706
Actively Recruiting
9
Artiva Investigational Site Tustin
Tustin, California, United States, 92780
Actively Recruiting
10
Artiva Investigational Site Jupiter
Jupiter, Florida, United States, 33458
Actively Recruiting
11
Artiva Investigational Site Miami
Miami, Florida, United States, 33143
Actively Recruiting
12
Artiva Investigational Site Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
13
Artiva Investigational Site Gainesville
Gainesville, Georgia, United States, 30501
Actively Recruiting
14
Artiva Investigational Site Norcross
Norcross, Georgia, United States, 30092
Actively Recruiting
15
Artiva Investigational Site Willowbrook
Willowbrook, Illinois, United States, 60527
Actively Recruiting
16
Artiva Investigational Site Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
17
Artiva Investigational Site Iowa Great Falls
Great Falls, Montana, United States, 59405
Actively Recruiting
18
Artiva Investigational Site Charlotte
Charlotte, North Carolina, United States, 28207
Actively Recruiting
19
Artiva Investigational Site Charlotte
Charlotte, North Carolina, United States, 28625
Actively Recruiting
20
Artiva Investigational Site Statesville
Statesville, North Carolina, United States, 27103
Actively Recruiting
21
Artiva Investigational Site Charleston
Charleston, South Carolina, United States, 29407
Actively Recruiting
22
Artiva Investigational Site Hixson
Hixson, Tennessee, United States, 37343
Actively Recruiting
23
Artiva Investigational Site Jackson
Jackson, Tennessee, United States, 38305
Actively Recruiting
24
Artiva Investigational Site Arlington
Arlington, Texas, United States, 76012
Actively Recruiting
25
Artiva Investigational Site Bellaire
Bellaire, Texas, United States, 77401
Actively Recruiting
26
Artiva Investigational Site Irving
Irving, Texas, United States, 75061
Actively Recruiting
27
Artiva Investigational Site Katy
Katy, Texas, United States, 77494
Actively Recruiting
28
Artiva Investigational Site Mesquite
Mesquite, Texas, United States, 75150
Actively Recruiting
29
Artiva Investigational Site Red Oak
Red Oak, Texas, United States, 75154
Actively Recruiting
30
Artiva Investigational Site Woodland
Woodland, Texas, United States, 77382
Actively Recruiting
31
Artiva Investigational Site Roanoke
Roanoke, Virginia, United States, 24016
Actively Recruiting
32
Artiva Investigational Site Brasília
Brasília, Brasília, Brazil
Actively Recruiting
33
Artiva Investigational Site Cuiabá
Cuiabá, Cuiabá, Brazil
Actively Recruiting
34
Artiva Investigational Site Porto Alegre
Porto Alegre, Porto Alegre, Brazil
Actively Recruiting
35
Artiva Investigational Site Rio Grande
Rio Grande, Porto Alegre, Brazil
Actively Recruiting
36
Artiva Investigational Site Sao Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
37
Artiva Investigational Site São Paulo
São Paulo, São Paulo, Brazil
Actively Recruiting
38
Artiva Investigational Site Plovdiv
Plovdiv, Plovdiv, Bulgaria
Actively Recruiting
39
Artiva Investigational Site Sofia
Sofia, Bulgaria, 1612
Actively Recruiting
40
Artiva Investigational Site Marseille
Marseille, France, 13005
Actively Recruiting
41
Artiva Investigational Site Montpellier
Montpellier, France, 34090
Actively Recruiting
42
Artiva Investigational Site Toulouse
Toulouse, France, 31059
Actively Recruiting
43
Artiva Investigational Site Bonn
Bonn, Bonn, Germany
Actively Recruiting
44
Artiva Investigational Site Munchen
München, Germany, 80336
Actively Recruiting
45
Artiva Investigational Site Brescia
Brescia, Italy, 25125
Actively Recruiting
46
Artiva Investigational Site Bydgoszcz
Bydgoszcz, Bydgoszcz, Poland
Actively Recruiting
47
Artiva Investigational Site Warszawa
Warsaw, Warszawa, Poland
Actively Recruiting
48
Artiva Investigational Site Vila Nova De Gaia
Vila Nova de Gaia, Portugal, 4434
Actively Recruiting
49
Artiva Investigational Site Bucuresti
Bucharest, Romania, 20125
Actively Recruiting
50
Artiva Investigational Site Bucharest
Bucharest, Romania, 50474
Actively Recruiting
51
Artiva Investigational Site Belgrade
Belgrade, Belgrade, Serbia
Actively Recruiting
52
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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