NCT06991114

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Artiva Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Allogeneic NK Cells	AlloNK, dosed after a conditioning regimen, combined with Rituximab.

Timeline

• Start date: 2025-07-09
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-05-25
• Last updated: 2025-12-24

Locations

26 sites across 8 countries: United States, Bulgaria, France, Germany, Italy, Portugal, Romania, Spain

Regulatory

• FDA-regulated drug study