Idiopathic Inflammatory Myopathies (IIMs), IIM, Myositis, Refractory Rheumatoid Arthritis (RA), Rheumatoid Arthritis (RA, Scleroderma, Sjogrens Disease, Sjogren Syndrome, Systemic Sclerosis (SSc)
Conditions
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
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.
Interventions
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
Sponsors
Artiva Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, single group design to establish safety and efficacy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | From enrollment until the end of treatment at Week 104. | Dose Limiting toxicities assessed in a incrementing dose design. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil, Bulgaria, France, Germany, Italy, Poland, Portugal, Romania, Serbia, Spain, United States
Contacts
CONTACTChanel Mansfield Director, Clinical Operations, MPH
STUDY_DIRECTORMichael Saddekni, M.D., PgDip, BCMAS
Artiva Therapeutics
Outcome results
None listed