OncoMatch/Clinical Trials/NCT06867991
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Is NCT06867991 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ofatumumab combined with daratumumab and Ofatumumab for anti-n-methyl-d-aspartate receptor encephalitis.
Treatment: Ofatumumab combined with daratumumab · Ofatumumab · Repeated intravenous immunoglobulin/plasma exchange therapy — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: high-dose methylprednisolone (methylprednisolone)
Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment
Must have received: IVIG (IVIG)
IVIG (0.4g/kg/d for 5 consecutive days)
Must have received: plasma exchange/immunoadsorption
at least 5 plasma exchange/immunoadsorption
Must have received: efgartigimod (efgartigimod)
at least 2 times of efgartigimod treatment
Cannot have received: experimental B cell depleting agent
Exception: unless CD19 B Cell levels have returned to above the lower limit of normal before randomization
Receipt of any experimental B cell depleting agent, unless CD19 B Cell levels have returned to above the lower limit of normal before randomization
Cannot have received: Natalizumab (Natalizumab)
Any of the following received within 3 months before randomization Natalizumab (Tysabri®)
Cannot have received: Cyclosporin (Cyclosporin)
Any of the following received within 3 months before randomization Cyclosporin
Cannot have received: Methotrexate (Methotrexate)
Any of the following received within 3 months before randomization Methotrexate
Cannot have received: Mitoxantrone (Mitoxantrone)
Any of the following received within 3 months before randomization Mitoxantrone
Cannot have received: Cyclophosphamide (Cyclophosphamide)
Any of the following received within 3 months before randomization Cyclophosphamide
Cannot have received: Azathioprine (Azathioprine)
Any of the following received within 3 months before randomization Azathioprine
Lab requirements
Blood counts
Platelet count < 75,000/μL; Hemoglobin < 8 g/dL; Total white blood cell count < 2,500 cells/mm3; Absolute neutrophil count < 1200 cells/μL; CD4 T lymphocyte count < 300 cells/µL
Liver function
AST > 2.5 × ULN; ALT > 2.5 × ULN; Total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome)
Aspartate aminotransferase (AST) > 2.5 × ULN; Alanine aminotransferase (ALT) > 2.5 × ULN; Total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome); Platelet count < 75,000/μL; Hemoglobin < 8 g/dL; Total white blood cell count < 2,500 cells/mm3; Absolute neutrophil count < 1200 cells/μL; CD4 T lymphocyte count < 300 cells/µL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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