Trial to Evaluate Efficacy and Safety of Bortezomib in Patients with Severe Autoimmune Encephalitis

Launched by JENA UNIVERSITY HOSPITAL · Jun 19, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients with severe autoimmune encephalitis, a condition where the body's immune system mistakenly attacks the brain. The study is testing a medication called bortezomib, which aims to specifically target the cells that produce harmful antibodies in the body. Currently, there are no dedicated therapies for this condition, and existing treatments mainly focus on managing symptoms. This trial seeks to determine how effective and safe bortezomib is for patients suffering from this serious disorder.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with severe autoimmune encephalitis, confirmed by the presence of specific autoantibodies in their bodily fluids. They should also have received a prior treatment called rituximab. Participants will be monitored for their response to the new treatment, and they will be required to provide informed consent before joining. It's important to note that pregnant or breastfeeding women, as well as those with certain health conditions, will not be eligible to participate. This trial offers hope for new therapeutic options for those affected by this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and / or serum
• • Pretreatment with rituximab
• • Age ≥18 years
• • signed informed consent
• • Women of childbearing potential (up to 2 years after menopause): negative pregnancy test
• Exclusion Criteria:
• • pregnancy/breast-feeding
• • acute infiltrative pulmonary and pericardial disease
• • malignant tumor under current chemotherapy
• • Simultaneous participation in another intervention study
• • Previous participation in this study
• • Known hypersensitivity to an ingredient of the investigational product
• • Continued therapy with glucocorticoids / rituximab during the study duration (last dose must be administered before the first dose of the investigational product)