drugset / Trial / NCT06581562
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
Recruiting
30 enrolled
IRIS Research and Development, LLC
Artiva Biotherapeutics, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-05-15
- Primary completion
- 2027-07
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AB-101 | Cell therapy | 1e+09 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 1000 mg | — |