A Phase II, Open-Label, Single-Center, Single-Arm Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Blinatumomab for Treatment of Patients with Autoimmune B-Cell driven Diseases including Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc) and Granulomatous Polyangiitis (GPA)

Condition studied

Granulomatous Polyangiitis, Systemic Lupus Erythematosus, Systemic Sclerosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence of treatment-emergent adverse events (adverse events up to week 12)

Endpoint detail

Incidence of treatment-emergent adverse events (adverse events from week 13 up to week 52), Reduction of Titers of significant autoantibodies such as anti-ds DNA antibodies, SCL-70 antibodies or Pr3 antibodies, Clinical efficacy (Selena SLEDAI in SLE patients, ACR-CRISS score in cutaneous SSc patients, BVAS Score in GPA patients)