1.3.1 Germany
Start of trial:
2025-11-14
Restart trial:
End of trial:
Early termination:
Reason for early termination:
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
EUCT number:
2025-523061-22-00
Protocol code:
BlinA-B
Table of Contents
1 Summary
1.1 Trial Information
Medical condition(s):
Granulomatous Polyangiitis, Systemic Lupus Erythematosus, Systemic Sclerosis
Trial Phase:
Therapeutic exploratory (Phase II)
Transition Trial:
No
Sponsor:
Universitaet Leipzig
Participants type:
Patients
Age range:
65+ years,18-64 years
Locations:
Germany
Main objective (English):
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA
1.2 Overall Trial status
Overall trial status:
Ongoing, recruiting
Start of Trial:
2025-11-14
End of trial:
Global end of trial:
Overall Trial Status:
Ongoing, recruiting
Application Trial Status:
| Member State | Application Trial Status | Decision Date |
|---|---|---|
| Germany | Ongoing, recruiting | 2025-09-26 |
1.3 Trial Notifications
1.4 Recruitment Notifications
1.4.1 Germany
Start of recruitment:
2025-11-20
Restart of recruitment:
End of recruitment:
1.5 Trial duration
Estimated recruitment start date in EU/EEA:
2025-09-30
Estimated end of trial date in EU/EEA:
2027-10-29
Estimated global end date of the trial:
1.5.1 Source of monetary or financial support
Organisation name:
Estimated recruitment start date in EU/EEA:
2025-09-30
Estimated end of trial date in EU/EEA:
2027-10-29
Estimated global end date of the trial:
1.5.1 Source of monetary or financial support
Organisation name:
1.6 Serious Breaches
1.7 Unexpected Events
1.8 Urgent Safety Measures
1.9 Temporary Halts
1.10 Corrective Measures
1.11 Applications
1.11.1 IN
Application type:
INITIAL
Submission date:
2025-07-09
1.11.1.1 Assessment Part I
Reference Member State:
Germany
Final conclusion:
Acceptable
Conclusion reporting date:
2025-09-24
1.11.1.2 Assessment Part II
| Member state | Final conclusion | Conclusion reporting date |
|---|---|---|
| Germany | Acceptable | 2025-09-08 |
1.11.1.3 Decision
| Member state | Decision | Decision date | Decision type |
|---|---|---|---|
| Germany | Authorised | 2025-09-26 | Decision |
1.11.2 NSM-1
Application type:
NON SUBSTANTIAL MODIFICATION
Submission date:
2025-11-18
1.11.2.1 Assessment Part I
Reference Member State:
Germany
Final conclusion:
Acceptable
Conclusion reporting date:
2025-09-24
1.11.2.2 Assessment Part II
| Member state | Final conclusion | Conclusion reporting date |
|---|
1.11.2.3 Decision
| Member state | Decision | Decision date | Decision type |
|---|---|---|---|
| Germany | Authorised | 2025-11-18 | Decision |
1.11.3 SM-1
Application type:
SUBSTANTIAL MODIFICATION
Submission date:
2026-02-20
1.11.3.1 Assessment Part I
Reference Member State:
Germany
Final conclusion:
Acceptable
Conclusion reporting date:
2026-03-17
1.11.3.2 Assessment Part II
| Member state | Final conclusion | Conclusion reporting date |
|---|---|---|
| Germany | Acceptable | 2026-03-20 |
1.11.3.3 Decision
| Member state | Decision | Decision date | Decision type |
|---|---|---|---|
| Germany | Authorised | 2026-03-25 | Decision |
2 Full trial information (Part I)
2.1 Trial details
2.1.1 Trial identifiers
2.1.1.1 Clinical trial identifiers
EU trial number:
2025-523061-22-00
Full title (English):
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)
Public title (English):
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
Protocol code:
BlinA-B
2.1.1.2 Secondary identifying numbers
WHO universal trial number (UTN):
ClinicalTrials.gov identifier (NCT number):
ISRCTN number:
2.1.1.3 Additional registries
2.1.2 Trial Information
2.1.2.1 Transition Trial
EudraCT number:
2.1.2.2 Trial Category
Trial phase:
Therapeutic exploratory (Phase II)
Trial category:
2
Justification for trial category:
Phase II Trial
2.1.2.3 Medical Conditions
Medical condition(s) (English):
Granulomatous Polyangiitis
Is the medical condition considered to be a rare disease:
No
Medical condition(s) (English):
Systemic Lupus Erythematosus
Is the medical condition considered to be a rare disease:
No
Medical condition(s) (English):
Systemic Sclerosis
Is the medical condition considered to be a rare disease:
No
Therapeutic area:
Diseases [C] - Immune System Diseases [C20]
2.1.2.4 Medical condition(s) MedDRA information
| Version | Level | Classification code | Term name | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072580 | Granulomatous polyangiitis | 10047065 |
| 21.1 | LLT | 10025139 | Lupus erythematosus systemic | 10028395 |
| 28.0 | LLT | 10079544 | Systemic sclerosis sine scleroderma | 10028395 |
2.1.2.5 Main objective
Trial scope:
Efficacy, Safety
Main objective (English):
Safety and tolerability of blinatumomab as treatment regime in patients with SLE, SSc or GPA
2.1.2.6 Secondary objective
| Secondary objective number | Secondary objective (English) |
|---|---|
| 1 | Long term safety of blinatumomab as treatment regime in patients with SLE, SSc or GPA |
| 2 | Evaluation of disease-related biomarkers such as: Anti ds-DNA antibodies in SLE, Pr3 antibodies in GPA, SCL-70 or RNAP III in diffuse cutaneous SSc |
| 3 | Clinical efficacy |
2.1.2.7 Principal inclusion criteria
| Inclusion criteria number | Principal inclusion criteria (English) |
|---|---|
| 1 | GENERAL INCLUSION CRITERIA: Age over 18 years |
| 10 | GPA patients: Active or refractory disease |
| 2 | SLE patients: Diagnosis of SLE according to EULAR/ ACR criteria for more than six months |
| 3 | SLE patients: Serologically active disease: Positivity for ANA (1:160) and anti dsDNA, defined as more than ULN and Hypocomplementemia of C3 or C4 |
| 4 | SLE patients: Prior treatment failure of at least two immunosuppressive agents |
| 5 | SLE patients: Clinical active disease: SLEDAI2k activity score > 6 and at least two BILAG B and/ or one BILAG A manifestation |
| 6 | SSc patients: Diagnosis of dcSSc (2013 ACR/EULAR criteria for systemic sclerosis and LeRoy criteria for dcSSc) |
| 7 | SSc patients: Disease onset from the first non-Raynaud symptoms within 6 years prior to screening visit. |
| 8 | GPA patients: Diagnosis of GPA according to the Chapel Hill Consensus Conference definitions |
| 9 | GPA patients: Positive serum Pr3-ANCA at screening or in medical history |
2.1.2.8 Principal exclusion criteria
| Exclusion criteria number | Principal exclusion criteria (English) |
|---|---|
| 1 | Prior treatment with cellular immunotherapy (CAR T) or T cell engaging Antibodies |
| 2 | History of allogeneic stem cell transplant |
| 3 | Known infectious comorbidities (HIV positivity, Hepatitis B/C) |
| 4 | Severely impaired cardiac function |
2.1.2.9 Primary end points
| End point criteria number | Primary end point (English) |
|---|---|
| 1 | Incidence of treatment-emergent adverse events (adverse events up to week 12) |
2.1.2.10 Secondary end points
| Secondary end point number | Secondary end point (English) |
|---|---|
| 1 | Incidence of treatment-emergent adverse events (adverse events from week 13 up to week 52) |
| 2 | Reduction of Titers of significant autoantibodies such as anti-ds DNA antibodies, SCL-70 antibodies or Pr3 antibodies |
| 3 | Clinical efficacy (Selena SLEDAI in SLE patients, ACR-CRISS score in cutaneous SSc patients, BVAS Score in GPA patients) |
2.1.2.11 Individual Participant Data (IPD) Sharing statement
Plan to share IPD:
No
Plan description:
2.1.2.12 Participants
Gender:
Male and Female
Age range:
65+ years, 18-64 years
Age range secondary identifier:
Clinical trial group:
Patients
Vulnerable population:
No
2.1.3 Protocol information
2.1.3.1 Study design
Period details:
| Number | Period title | Period description | Allocation method | Blinding used | Roles blinded | Blinding implementation details | Arm details |
|---|
2.1.4 Scientific advice and paediatric investigation plan (PIP)
Competent authorities that have provided scientific advice:
EMA paediatric investigation number:
2.1.5 Associated clinical trials
| Associated EU CTA number | Full title | Sponsor for associated clinical trial |
|---|
2.1.7 References
Reference to publication:
Reference link to publication:
2.2 Products
2.2.1 Role: Test Name: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
2.2.1.1 Product: BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Type
Product
Excluded MSCs
2.2.1.1.1 Product details
Medicinal product name:
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
EU medicinal product number/medicinal product unique ID:
PRD3418637
Pharmaceutical form:
SOLUTION FOR INFUSION
Strength:
Medicinal product other name:
Is this a specific paediatric formulation:
No
Product authorisation status:
Authorised
Medicinal product role in trial:
Test
Sponsors product code:
2.2.1.1.2 Products characteristics
Medicinal product characteristics:
Other medicinal product:
2.2.1.1.3 Dosage and administration Details
Route of administration:
INTRAVENOUS
Maximum duration of treatment:
10 Day(s)
Maximum daily dose allowed:
28
Daily dose unit of measure:
µg microgram(s)
Maximum total dose allowed:
280
Total dose unit of measure:
µg microgram(s)
2.2.1.1.4 Information about the modification of the medicinal product
Has the medicinal product been modified in relation to its Marketing Authorisation:
No
Description of the modification:
2.2.1.1.5 Product classification
Anatomical Therapeutic Chemical (ATC) Codes:
L01FX07
ATC name:
-
ATC level:
5
2.2.1.1.6 Product authorisation details
MA holder
AMGEN EUROPE B.V.
MA authorisation country
EU
Marketing authorisation number
EU/1/15/1047/001
Centralised procedure/MRP/DCP/registration procedure number
EMEA/H/C/003731
2.2.1.1.7 Orphan designation
Does this product have an orphan drug designation:
No
Designation number for orphan drug:
2.2.1.1.8 Active substance
Classification:
Protein - Other
Active Substance name:
BLINATUMOMAB
Active substance name synonyms:
Active Substance other descriptive name:
EU Active Substance Code:
SUB35403
Strength:
Status:
Authorised
2.2.1.1.9 Advanced therapy medicinal product
2.2.1.1.10 Device associated with medicinal product
| Product used in combination with a device | Product ID | Device trade name | Description of the device | Type of device | Device has CE mark | Device notified body |
|---|
2.2.1.1 Compliance with (GMP) for the medicinal product
Authorisation number of manufacturing and import:
3 Trial Results
3.1 Summaries of Results
3.2 Layperson Summaries of Results
3.3 Clinical Study Reports
4 Locations and contact points
4.1 Locations
4.1.1 Germany - Ongoing, recruiting
Planned number of subjects:
5
4.1.1.1 Site: Universitaet Leipzig
OMS ID:
ORG-100000273
Department name:
Early Clinical Trials Unit Leipzig
Site location:
Liebigstrasse 22, Zentrum-Suedost
Site street address:
Liebigstrasse 22
Site city:
Leipzig
Site post code:
04103
Site country:
Germany
First name:
Vladan
Last name:
Vucinic
Title:
Dr.
Telephone number:
+493419712674
Email:
ectul@medizin.uni-leipzig.de
4.1.2 Countries outside of the European Economic Area
Countries outside of the European Economic Area:
Participants in the rest of the world:
0
4.2 Sponsors
4.2.1 Sponsor:
Universitaet Leipzig
4.2.1.1 Sponsor details
ID:
ORG-100000273
Name of sponsor organisation:
Universitaet Leipzig
Address:
Ritterstrasse 26, Zentrum
Town/City:
Leipzig
Post code:
04109
Country:
Germany
Phone:
Email address:
4.2.1.2 Scientific contact point
Name of organisation:
Universitaet Leipzig
Functional contact point name:
Susanne Melzer
Phone:
+493419716317
Email address:
blinab@zks.uni-leipzig.de
4.2.1.3 Public contact point
Name of organisation:
Universitaet Leipzig
Functional contact point name:
Susanne Melzer
Phone:
+493419716317
Email address:
blinab@zks.uni-leipzig.de
4.2.1.4 Third parties associated with the trial
| ID | Organisation Name | Address | City | Postcode | Country | Phone | Duties |
|---|
4.2.2 Responsibilities of the sponsor
Sponsor(s) responsible for compliance:
Sponsor(s) responsible for being a contact point:
Sponsor(s) responsible for implementing the measures taken in accordance with article 77: