Clinical trial 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Refractory Rheumatoid Arthritis (RA)
Idiopathic Inflammatory Myopathies (IIMs)
Systemic Sclerosis (SSc)
Rheumatoid Arthritis (RA
IIM
Myositis
Scleroderma
Sjogren Syndrome
Sjogrens Disease
Keywords: Refractory Rheumatoid Arthritis
AlloNK
Idiopathic Inflammatory Myopathies
Systemic Sclerosis
Sjögren's Disease
Refractory RA
Cell Therapy
Allogeneic NK Cells
Allogeneic Cell Therapy
non-genetically modified
rituximab
cord blood cells
ADCC enhancement
outpatient
community
Lead sponsor: Artiva Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single group design to establish safety and efficacy.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety
timeFrame: From enrollment until the end of treatment at Week 104.
Secondary outcomes:
measure: Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR)
timeFrame: Week 52
measure: Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI)
timeFrame: Week 52
measure: Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS)
timeFrame: Week 52
measure: Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS)
timeFrame: Week 52
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Artiva Clinical Trial Site
state: Arizona
city: Aventura
country: United States
facility: Artiva Clinical Trial Site
state: Florida
city: Plantation
country: United States
facility: Artiva Clinical Trial Site
state: Florida
city: Willowbrook
country: United States
facility: Artiva Clinical Trial Site
state: Illinois
city: Charlotte
country: United States
facility: Artiva Clinical Trial Site
state: North Carolina
city: Arlington
country: United States
facility: Artiva Clinical Trial Site
state: Texas
city: Houston
country: United States
facility: Artiva Clinical Trial Site
state: Texas
Study officials:
affiliation: Artiva Therapeutics
name: Michael Saddekni, M.D., PgDip, BCMAS
role: STUDY_DIRECTOR
References: