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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

Sjogren's Syndrome

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 : 2025-07-09
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

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Artiva Investigational Site Tuscaloosa

Tuscaloosa, alabama, United States, 35406

RECRUITING

United States, Arizona

Artiva Investigational Site Phoenix

Phoenix, arizona, United States, 85037

RECRUITING

United States, California

Artiva Investigational Site Covina

Covina, California, United States, 91723

RECRUITING

United States, California

Artiva Investigational Site Los Alamitos

Los Alamitos, California, United States, 90720

RECRUITING

United States, Florida

Artiva Investigational Site Aventura

Aventura, florida, United States, 33180

RECRUITING

United States, Florida

Artiva Investigational Site Jupiter

Jupiter, florida, United States, 33458

RECRUITING

United States, Florida

Artiva Investigational Site Plantation

Plantation, florida, United States, 33324

RECRUITING

United States, Illinois

Artiva Investigational Site Willowbrook

Willowbrook, Illinois, United States, 60527

RECRUITING

United States, Iowa

Artiva Investigational Site Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, North Carolina

Artiva Investigational Site Charlotte

Charlotte, North Carolina, United States, 28207

RECRUITING

United States, North Carolina

Artiva Investigational Site Charlotte

Charlotte, North Carolina, United States, 28625

RECRUITING

United States, Tennessee

Artiva Investigational Site Hixson

Hixson, Tennessee, United States, 37343

RECRUITING

United States, Texas

Artiva Investigational Site Arlington

Arlington, Texas, United States, 76012

RECRUITING

United States, Texas

Artiva Investigational Site Katy

Katy, Texas, United States, 77494

RECRUITING

United States, Texas

Artiva Investigational Site Mesquite

Mesquite, Texas, United States, 75150

RECRUITING

United States, Texas

Artiva Investigational Site Woodland

Woodland, Texas, United States, 77382

RECRUITING

Bulgaria,

Artiva Investigational Site Sofia

Sofia, Bulgaria, 1612

RECRUITING

France,

Artiva Investigational Site Marseille

Marseille, France, 13005

RECRUITING

France,

Artiva Investigational Site Montpellier

Montpellier, France, 34090

RECRUITING

France,

Artiva Investigational Site Toulouse

Toulouse, France, 31059

RECRUITING

Germany,

Artiva Investigative City Munich

München, Germany, 80336

RECRUITING

Italy,

Artiva Investigational Site Brescia

Brescia, Italy, 25125

RECRUITING

Portugal,

Artiva Investigational Site Vila Nova De Gaia

Vila Nova de Gaia, Portugal, 4434

RECRUITING

Romania,

Artiva Investigational Site Bucharest

Bucharest, Romania, 20125

RECRUITING

Romania,

Artiva Investigational Site Bucharest

Bucharest, Romania, 50474

RECRUITING

Spain,

Artiva Investigative City Seville

Seville, Spain, 41701