Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRIS Research and Development, LLC

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

30 Participants
are divided into 4 treatment groups

Sponsors and collaborators

IRIS Research and Development, LLC

Lead sponsor

Artiva Biotherapeutics, Inc.

Collaborator