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Taking people in GermanyPhase 2

Tests blinatumomab in people with lupus, scleroderma or granulomatosis with polyangiitis

Tests blinatumomab, a B-cell targeting drug, for safety in adults with lupus, scleroderma or GPA.

Key facts

Who runs it
Universitaet Leipzig
Where
Leipzig, GermanySee the site
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
5 people, planned
Started
14 Nov 2025
Expected to end
29 Oct 2027
Type of study
Interventional
Record updated
2 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Germany

  • Universitaet LeipzigLeipzig, GermanyTaking people

About the trial

What the trial wants to find out

Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests blinatumomab in people with lupus, scleroderma or granulomatosis with polyangiitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
2 October 2026