MOR202 for Refractory MN

Exclusion Criteria

• •Clinically relevant neutropenia (neutrophils \< 1.5 x 109/L), anemia (Hb levels \<9.0 g/dL), thrombocytopenia (platelet count \< 150.000/mm3), increased liver transaminase or bilirubin levels (total bilirubin, aspartate aminotransferase or alanine aminotransferase \>1.5 x ULN, alkaline phosphatase \>3.0 x ULN).
• •Significant uncontrolled cardiovascular disease (including arterial or venous thrombotic or embolic events over the last three months) or cardiac insufficiency (New York Heart Association \[NYHA\] class IV) as judged by the investigator.
• •Clinically relevant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
• •History of significant cerebrovascular disease (stroke or transitory ischemic attack over the last three months) or sensory or motor neuropathy of toxicity ≥ grade 3.
• •Any clinical condition that in the investigator judgment could affect the possibility to complete the study or could have a major confounding effect on study findings and data interpretation.
• •Known intolerance to the study drug or its excipients
• •Any viral, bacterial or fungal infection without complete symptoms resolution from at least two weeks.
• •Serologic or virologic markers positive for HIV, hepatitis C (patients with positive antihepatitis C virus \[anti-HCV\] antibody but negative HCV RNA polymerase chain reaction \[PCR\] can enroll) or active or latent hepatitis B (patients with positive hepatitis B surface antigen \[HBsAg\] are excluded). Patients with isolated positive hepatitis B core antibody \[anti-HBc\], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll.
• •History of malignancy within the prior 5 years.
• •Participation in other clinical trials within 4 weeks of signing the consent form.
• •Expected need of anti SARS Cov 2 vaccination during the study period
• •Pregnancy or breast-feeding.
• •Childbearing potential in males and females non using an highly effective method of contraception according to 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01-About\_HMA/Working\_Groups/CTFG/2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1\_updated.pdf).
• •Legal incapacity or limited legal capacity.