Overview
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.
Principal investigator
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.
* 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.
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