Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
Trial Parameters
Brief Summary
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
Inclusion Criteria: General Inclusion Criteria (applicable to subjects in all 4 studied indications) 1. Males or female subjects, ≥ 18 years of age at the time of signing informed consent. 2. Ability to understand the requirements of the study. 3. Willingness to provide written informed consent. 4. Willingness to comply with the study protocol procedures. 5. Women of childbearing potential and all male participants must agree to use two acceptable methods of contraception together to avoid pregnancy. The following are examples of acceptable methods of contraception including: 1. Established use of oral, inserted, injected, or implanted hormonal methods of contraception. 2. Correctly placed copper containing intrauterine device (IUD). 3. Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream, suppository). 4. Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate. 5. Bilateral tubal ligation or bilateral salpingectomy.