Evaluating Bortezomib for Severe Autoimmune Encephalitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the efficacy and safety of bortezomib, a proteasome inhibitor, in patients diagnosed with severe autoimmune encephalitis characterized by autoantibodies against neuronal surface proteins. Currently, there are no specific therapies for this condition, and existing treatments often provide insufficient relief. The study will involve administering bortezomib to target the antibody-producing plasma cells, potentially leading to improved clinical outcomes. Participants will be monitored for both efficacy and safety throughout the trial.

Why it matters

Who can join: the full rules

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)

Where it's running

• Ludwig-Maximilians-Universität München, Klinikum Großhadern
  München, Bavaria, Germany Recruiting
• Universitätsklinikum Würzburg
  Würzburg, Bavaria, Germany Recruiting
• Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie
  Jena, Germany, Germany Recruiting
• Medizinische Hochschule Hannover
  Hanover, Niedersachen, Germany Recruiting
• Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
  Berlin, Germany Recruiting
• Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie
  Bochum, Germany Recruiting

Study contacts

• Study coordinator: Christian Geis, Prof.
• Email: Christian.Geis@med.uni-jena.de
• Phone: +49 (0) 3641

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pregnant Women with Neuroimmune Diseases: A long-term follow-up study

  This study follows women with neuroimmune diseases and healthy controls through pregnancy and up to ten years to see how pregnancy affects disease activity and outcomes for both mother and baby.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT07653984

• Identifying new autoantibodies and causes of autoimmune encephalitis

  This project looks for new autoantibodies and other disease features in adults with autoimmune encephalitis to help improve diagnosis and care.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome, RM · NCT07477015

• ART5803 for people with anti-NMDAR encephalitis or anti-NMDAR autoantibody–linked psychiatric disease

  This will test whether ART5803, a one‑armed antibody, is safe and can help adults with anti‑NMDAR encephalitis or anti‑NMDAR autoantibody‑associated psychiatric symptoms.

  Recruiting Phase 2 Arialys Australia Pty Ltd · Seoul · NCT07093333

• Universal CD19/BCMA CAR T-cell therapy for relapsed or refractory neurological autoimmune diseases

  This will test whether a single infusion of universal CD19/BCMA CAR T-cells given after chemotherapy helps adults with relapsed or refractory neurological autoimmune diseases who have CD19- or BCMA-positive B cells.

  Recruiting Early Phase 1 Tianjin Huanhu Hospital · Tianjin · NCT06939166

• Using Calculus Bovis Sativus to treat adult encephalitis

  This study is testing a traditional Chinese medicine called Calculus Bovis Sativus to see if it can help adults with autoimmune encephalitis feel better.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT06584045

• Identifying biomarkers for autoimmune diseases affecting the nervous system

  This study is trying to find specific markers in the blood of people with autoimmune diseases affecting the nervous system, like Multiple Sclerosis, to help with early diagnosis and better treatment options.

  Recruiting Tongji Hospital · Wuhan · NCT06502015

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.