Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Enc
Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons a
| Condition(s) | Anti-N-Methyl-D-Aspartate Receptor Encephalitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons are pathogenic and are mainly produced by autoreactive B cells and plasma cells. Therefore, early elimination of these abnormal immune cells is crucial for rapid improvement of the patient's condition. This study aims to explore the efficacy and safety of B cell depletion therapy (ofatumumab) followed by plasma cell depletion therapy (daratumumab) in the treatment of severe anti-NMDAR autoimmune encephalitis. |
| Who can participate | Inclusion Criteria: 1. Aged 12 years and above 2. Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen 3. Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod treatment 4. mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment 5. Informed consent or guardian signed informed consent Exclusion Criteria: 1. Severe active or chronic infection in the opinion of the investigator. 2. Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichev |
| Ages | 12 Years |
| Sex | All |
| Lead sponsor | The First People's Hospital of Changzhou |
| Locations | Zhengzhou, Henan, China; Changzhou, Jiangsu, China |
| Start date | 2024-11-08 |
| NCT ID | NCT06867991 |
| Official listing | https://clinicaltrials.gov/study/NCT06867991 |