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.
Purpose
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.
Conditions
- Refractory Rheumatoid Arthritis (RA)
- Idiopathic Inflammatory Myopathies (IIMs)
- Systemic Sclerosis (SSc)
- Rheumatoid Arthritis (RA
- IIM
- Myositis
- Scleroderma
- Sjogren Syndrome
- Sjogrens Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open label, single group design to establish safety and efficacy.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AlloNK |
AlloNK, dosed after a conditioning regimen, combined with Rituximab. |
|
Recruiting Locations
Tuscaloosa, Alabama 35406
Phoenix, Arizona 85037
Covina, California 91723
Los Alamitos, California 90720
Aventura, Florida 33180
Jupiter, Florida 33458
Plantation, Florida 33324
Willowbrook, Illinois 60527
Iowa City, Iowa 52242
Charlotte, North Carolina 28207
Charlotte, North Carolina 28625
Hixson, Tennessee 37343
Arlington, Texas 76012
Katy, Texas 77494
Mesquite, Texas 75150
Woodland, Texas 77382
More Details
- Status
- Recruiting
- Sponsor
- Artiva Biotherapeutics, Inc.
Study Contact
Chanel Mansfield Director, Clinical Operations, MPH1 858 223 7001
clinicaltrials@artivabio.com
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.