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NCT06991114 | RECRUITING | Refractory Rheumatoid Arthritis (RA)

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.
Sponsor:

Artiva Biotherapeutics, Inc.

Brief Summary:

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.

Condition or disease

Refractory Rheumatoid Arthritis (RA)

Idiopathic Inflammatory Myopathies (IIMs)

Systemic Sclerosis (SSc)

Rheumatoid Arthritis (RA

IIM

Myositis

Scleroderma

SHOGREN SUNDROME

Sjogrens Disease

Intervention/treatment

Allogeneic NK Cells

Phase

PHASE2

Detailed Description:

An open-label Phase 2a study to evaluate the safety and efficacy of AlloNK®, an allogeneic cord blood-derived NK cell therapy, in combination with rituximab in relapsing forms of B-cell dependent rheumatologic diseases. AlloNK® (also known as AB-101) is a non-genetically modified, allogeneic, off-the-shelf, cryopreserved cord blood-derived NK cell therapy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2028-01
Estimated Study Completion Date : 2029-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
For Subjects with Refractory Rheumatoid Arthritis (RA)
  • * Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria.
  • * Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.
  • * High-sensitivity C-reactive protein (hs-CRP) \> 3 mg/L or Erythrocyte Sedimentation Rate (ESR) \> 28 mm/hr.
  • * Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.
  • * Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.
  • For subjects with Sjögren's Disease (SjD)
  • * Prior diagnosis of Primary SjD as per 2016 ACR/EULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.
  • * Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \> 6.
  • * Salivary Flow Rate \> 0.1 mL/min on stimulation.
  • For subjects with Idiopathic Inflammatory Myopathies (IIMs)
  • * Presence of a positive autoantibody (ANA \>1:80 or RNP or SSA/SSB or other myositis specific autoantibodies.
  • * Refractory IIM as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.
  • * Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.
  • For Subjects with Systemic Sclerosis (SSc)
  • * Diagnosis of SSc in accordance with the ACR/EULAR 2013 classification.
  • * Modified Rodnan skin score (mRSS) \> 10.
  • * Initial confirmatory diagnosis within 8 years of screening.
  • * Refractory SSc as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.
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.

Location Details

NCT06991114

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How to Participate

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Locations

RECRUITING

United States, Arizona

Artiva Clinical Trial Site

Tucson, Arizona, United States, 85748

RECRUITING

United States, Florida

Artiva Clinical Trial Site

Aventura, Florida, United States, 33180

RECRUITING

United States, Florida

Artiva Clinical Trial Site

Plantation, Florida, United States, 33324

RECRUITING

United States, Illinois

Artiva Clinical Trial Site

Willowbrook, Illinois, United States, 60527

RECRUITING

United States, North Carolina

Artiva Clinical Trial Site

Charlotte, North Carolina, United States, 28625

RECRUITING

United States, Texas

Artiva Clinical Trial Site

Arlington, Texas, United States, 76012

RECRUITING

United States, Texas

Artiva Clinical Trial Site

Houston, Texas, United States, 83506