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), BlinA-B trial
Key facts
- Where
- Leipzig, NémetországSee the site
- Phase
- 2. fázis
Where in Németország
- Universitaet LeipzigLeipzig, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaet Leipzig
- Trial code
- EU 2025-523061-22-00
- Record updated
- 2026. október 2.
- Original description
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPARead full original descriptionShow less
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)
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA
Inclusion: GENERAL INCLUSION CRITERIA: Age over 18 years; GPA patients: Active or refractory disease; SLE patients: Diagnosis of SLE according to EULAR/ ACR criteria for more than six months; SLE patients: Serologically active disease: Positivity for ANA (1:160) and anti dsDNA, defined as more than ULN and Hypocomplementemia of C3 or C4; SLE patients: Prior treatment failure of at least two immunosuppressive agents; SLE patients: Clinical active disease: SLEDAI2k activity score > 6 and at least two BILAG B and/ or one BILAG A manifestation; SSc patients: Diagnosis of dcSSc (2013 ACR/EULAR criteria for systemic sclerosis and LeRoy criteria for dcSSc); SSc patients: Disease onset from the first non-Raynaud symptoms within 6 years prior to screening visit; GPA patients: Diagnosis of GPA according to the Chapel Hill Consensus Conference definitions; GPA patients: Positive serum Pr3-ANCA at screening or in medical history.
Exclusion: Prior treatment with cellular immunotherapy (CAR T) or T cell engaging Antibodies; History of allogeneic stem cell transplant; Known infectious comorbidities (HIV positivity, Hepatitis B/C); Severely impaired cardiac function.