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.

Artiva Biotherapeutics

Status and phase

Enrolling

Phase 2

Conditions

Myositis

Refractory Rheumatoid Arthritis (RA)

Sjogren Syndrome

Sjogrens Disease

Scleroderma

Rheumatoid Arthritis (RA

Systemic Sclerosis (SSc)

IIM

Idiopathic Inflammatory Myopathies (IIMs)

Treatments

Drug: Allogeneic NK Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT06991114

AB-101-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.