About this trial
This study will evaluate the safety and activity of AB-101 in combination with rituximab in B-cell associated autoimmune diseases where rituximab is currently FDA approved (e.g., Rheumatoid Arthritis (RA), Pemphigus Vulgaris (PV), Granulomatosis with polyangiitis (GPA)/microscopic polyangiitis (MPA) as a therapeutic, or is recommended (e.g., in Systemic Lupus Erythematosus (SLE) as a cornerstone for disease management.
Eligibility criteria
Qualifiers
Males or female subjects, ≥ 18 years of age at the time of signing informed consent.
Ability to understand the requirements of the study.
Willingness to provide written informed consent.
Willingness to comply with the study protocol procedures.
Disqualifiers
Immunoglobulin replacement therapies (IV or SC)
Plasmapheresis. 8. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant, or are due to receive such transplantation.
History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's)
Significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, Felty's syndrome)
Trial design
Treatments tested in this trial
- AB-101
- Rituximab
- Cyclophosphamide
- Fludarabine
Treatment groups
Sponsors and collaborators
IRIS Research and Development, LLC
Lead sponsor
Artiva Biotherapeutics, Inc.
Collaborator