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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.

NCT06991114

RecruitingPhase 2

Sponsor: Artiva Biotherapeutics, Inc.

Conditions: Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA, IIM

Interventions: Allogeneic NK Cells

Countries: United States, Brazil, Bulgaria, France, Germany, Italy, Poland, Portugal

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (52)

Tuscaloosa, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Covina, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Tustin, California, United States
Jupiter, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Gainesville, Georgia, United States
Norcross, Georgia, United States
Willowbrook, Illinois, United States
Iowa City, Iowa, United States
Great Falls, Montana, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Charleston, South Carolina, United States
Hixson, Tennessee, United States
Jackson, Tennessee, United States
Arlington, Texas, United States
Bellaire, Texas, United States
Irving, Texas, United States
Katy, Texas, United States
Mesquite, Texas, United States
Red Oak, Texas, United States
Woodland, Texas, United States
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