Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases
Phase 1
30
about 4.6 years
18+
1 site in FL
What this study is about
This trial is testing a treatment combining AB-101 with rituximab for autoimmune diseases like Granulomatosis With Polyangiitis, Pemphigus Vulgaris, Rheumatoid Arthritis, and Systemic Lupus Erythematosus. The goal is to assess the safety and effectiveness of this combination therapy.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take AB-101
- 2.Take Cyclophosphamide
- 3.Take Fludarabine
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cyclophosphamide (Alkylating chemotherapy; crosslinks DNA strands), fludarabine, rituximab (Monoclonal antibody; targets CD20 on B-cells to destroy them)
infusion
Primary: Incidence of Serious Adverse Events (SAE) and causality assessment, Incidence of adverse events and relationship to study drug
Secondary: GPA / MPA: Change from baseline in the Birmingham Vasculitis Activity Score at Week 12 and 24, PV: Change from baseline in the Pemphigus Disease Area Index (PDAI) at Week 12 and 24, RA: Change From Baseline in DAS28 at Week 12 and 24, SLE: Change from baseline in the SLE Disease Activity Index (SLEDAI) at Week 12 and 24
Immune