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.

ConditionsRefractory Rheumatoid Arthritis (RA)Idiopathic Inflammatory Myopathies (IIMs)Systemic Sclerosis (SSc)Rheumatoid Arthritis (RA IIM Myositis Scleroderma Sjogren Syndrome Sjogrens Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorArtiva Biotherapeutics, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

Allogeneic NK Cells

Treatment groups

90 Participants

are divided into 1 treatment group

Locations

Brazil

Artiva Investigational Site Brasília BrasíliaBrasília, Brazil

Artiva Investigational Site Cuiabá CuiabáCuiabá, Brazil

Artiva Investigational Site Porto Alegre Porto AlegrePorto Alegre, Brazil

Artiva Investigational Site Rio Grande Rio GrandePorto Alegre, Brazil

Sponsors and collaborators

Artiva Biotherapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov