Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06991114

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, Sjf6gren'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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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