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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523061-22-00

Acronym

BlinA-B

Enrollment

Registered

2025-09-26

Start date

2025-11-14

Completion date

Unknown

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis, Systemic Lupus Erythematosus, Granulomatous Polyangiitis

Brief summary

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

Detailed description

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)

Interventions

DRUGBLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent adverse events (adverse events up to week 12)	—

Secondary

Measure	Time frame
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)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026