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.

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.

• Allogeneic NK Cells (Drug): AlloNK, dosed after a conditioning regimen, combined with Rituximab.

Primary outcomes

• Safety [From enrollment until the end of treatment at Week 104.]: Dose Limiting toxicities assessed in a incrementing dose design.

Secondary outcomes

• Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR) [Week 52]: Efficacy
• Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI) [Week 52]: Efficacy
• Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS) [Week 52]: Efficacy
• Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS) [Week 52]: Efficacy

Sex: All, ages: 18 Years to any

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.

• Michael Saddekni, M.D., PgDip, BCMAS, Study director, Artiva Therapeutics