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.

Phase 2

Recruiting

• Conditions: Refractory Rheumatoid Arthritis (RA); Idiopathic Inflammatory Myopathies (IIMs); Systemic Sclerosis (SSc); Rheumatoid Arthritis (RA; IIM; Myositis; Scleroderma; Sjogren Syndrome; Sjogrens Disease
• Interventions: Drug: Allogeneic NK Cells

• Registration Number: NCT06991114
• Lead Sponsor: Artiva Biotherapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Study First Posted: 2025-05-25
• Status Verified: 2025-06
• Study Start: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2028-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AlloNK	Allogeneic NK Cells	AlloNK, dosed after a conditioning regimen, combined with Rituximab.

Primary Outcome Measures

Name	Time	Method
Safety	From enrollment until the end of treatment at Week 104.	Dose Limiting toxicities assessed in a incrementing dose design.

Secondary Outcome Measures

Name	Time	Method
Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI)	Week 52	Efficacy
Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR)	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

Trial Locations

Locations (1)

Artiva Clinical Trial Site; 🇺🇸 Houston, Texas, United States