Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.
NCT Number: NCT06581562
Acronym: IRIS-RD-01
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Rheumatoid Arthritis|Pemphigus Vulgaris|Granulomatosis With Polyangiitis|Systemic Lupus Erythematosus
Interventions: DRUG: AB-101|DRUG: Rituximab|DRUG: Cyclophosphamide|DRUG: Fludarabine
Sponsor: IRIS Research and Development, LLC
Collaborators: Artiva Biotherapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2028-12
Locations: IRIS Research and Development, LLC, Plantation, Florida, 33324, United States

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.

Primary Outcome Measures: Incidence of adverse events and relationship to study drug, We will evaluate the Incidence of adverse events and relationship to study drug, From the time of consent through 104 weeks after initiation of study treatment|Incidence of Serious Adverse Events (SAE) and causality assessment, We will evaluate the Incidence of adverse events and relationship to study drug, From the time of consent through 104 weeks after initiation of study treatment|Total hospitalizations, duration of hospitalizations through the course of the study, We will evaluate the Incidence of adverse events and relationship to study drug, From the time of consent through 104 weeks after initiation of study treatment
Secondary Outcome Measures: RA: Change From Baseline in DAS28 at Week 12 and 24, RA: Change From Baseline in DAS28 at Week 12 and 24, Week 12 through 24|PV: Change from baseline in the Pemphigus Disease Area Index (PDAI) at Week 12 and 24, PV: Change from baseline in the Pemphigus Disease Area Index (PDAI) at Week 12 and 24, Week 12 through 24|GPA / MPA: Change from baseline in the Birmingham Vasculitis Activity Score at Week 12 and 24, GPA / MPA: Change from baseline in the Birmingham Vasculitis Activity Score at Week 12, Week 12 through 24|SLE: Change from baseline in the SLE Disease Activity Index (SLEDAI) at Week 12 and 24, SLE: Change from baseline in the SLE Disease Activity Index (SLEDAI) at Week 12 and 24, Week 12 through 24
Other Outcome Measures: Pharmacokinetics and Immunogenicity, Blood samples for pharmacokinetic analysis and immunogenicity will be collected according to the SoA, at baseline and according to the scheduled of assessments|Patient Reported Outcomes, Patient Reported Outcomes, from the time of consent through 104 weeks after initiation of styudy treatment|Pharmacodynamic Biomarkers, The following biomarkers will be measured at baseline and according to the scheduled of assessments. Autoantibodies: ANA, anti-dsDNA, aCL (IgG, IgM, IgA isotypes), anti-Sm, and anti- C1q 2. Serum immunoglobulin isotypes: IgA, IgG, IgM 3. Serum complement (C3, C4) 4. Serum cytokines/chemokines, urinary biomarkers 5. Peripheral B cell subsets, T and NK lymphocytes 6. DSG 1 and DSG 3 autoantibodies, from the time of consent through 104 weeks after initiation of styudy treatment