2025-523061-22-00RecruitingPhase 2
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
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Oct 2026
Brief summary (registry, in English)
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 14 Nov 2025
- Lead sponsor
- Universitaet Leipzig
- EU CT number
- 2025-523061-22-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 5
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active or hard-to-treat lupus (SLE), systemic sclerosis (SSc) or granulomatosis with polyangiitis (GPA). It tests the safety and effect of blinatumomab.
- Age
- Over 18 years
- Sex
- All sexes can join.
- Disease stage
- SLE: diagnosed for more than six months, active disease with SLEDAI2k score > 6 and at least two BILAG B and/or one BILAG A manifestation. SSc: diffuse cutaneous form (dcSSc), disease started within 6 years before screening. GPA: active or refractory disease.
- Earlier treatment
- SLE: at least two immunosuppressive drugs did not work. Cannot have had CAR T cell therapy or T cell engaging antibodies before.
- Biomarker or test result
- SLE: ANA positive (1:160) and anti dsDNA above the upper limit of normal, with low C3 or C4. GPA: positive Pr3-ANCA in the blood at screening or in the past.
Main reasons for not taking part
- Earlier CAR T or T cell engaging antibody treatment
- Earlier allogeneic stem cell transplant
- HIV, hepatitis B or hepatitis C infection
- Severely impaired heart function
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with cellular immunotherapy (CAR T) or T cell engaging Antibodies
Other illness
- History of allogeneic stem cell transplant
- Known infectious comorbidities (HIV positivity, Hepatitis B/C)
- Severely impaired cardiac function
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaet Leipzig | Leipzig | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.