Phase 2 Rare Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with NMDAR encephalitis, meaning they had a rapid change in mental status consistent with autoimmune encephalitis, and a specific antibody (anti-NMDA receptor IgG) was found in their spinal fluid, confirmed by a study-approved laboratory.
• People aged 12 years or older at the time of signing consent. Those under 18 must weigh at least 40 kilograms (about 88 pounds).
• People (or their legal representatives) who are willing and able to sign consent forms, including any privacy-related authorisations required in their country.
• People who are sexually active with a partner who could become pregnant, and who agree to use a condom with spermicide from the start of the study until at least 6 months after the last dose of the study drug; the trial also recommends that those partners use an additional highly effective contraception method.
• People who could become pregnant, who are sexually active with a partner who could get them pregnant, and who agree to use a highly effective contraception method (such as an intrauterine device, hormonal contraception combined with a barrier method, or complete abstinence as a consistent lifestyle choice) from screening until 12 months after the last dose of the study drug.
• People who are willing to avoid other immune-modifying treatments for NMDAR encephalitis during the study.
• People who have already received at least 3 days of high-dose steroid treatment (methylprednisolone 1000 mg by IV, or an equivalent steroid) within the 90 days before joining the study, plus at least one of the following: a course of intravenous immunoglobulin (IVIg) at a specified dose, or a course of plasma exchange (5 to 6 sessions). These treatments may be given during the screening period but must be finished before the person is formally enrolled.
• People who have at least moderate disability, as measured by a specific disability scale called the Modified Rankin Score (a score of 3 or higher), confirmed by the study doctors at screening.
• People who are able and willing to attend study visits and complete the full study.

Who may not be able to join:

• People with any condition that, in the investigator's opinion, would make participation unsafe or affect how the study results can be interpreted — this specifically includes a history of herpes simplex virus encephalitis in the past 5 years, or a known condition involving damage to the brain's protective coating (such as multiple sclerosis).
• People who have an active or ongoing serious infection at the time of screening.
• People who have previously had a solid organ transplant (such as a kidney or heart) or a cell-based transplant.
• People who are currently enrolled in, or have recently participated in, another clinical trial using an investigational treatment within 4 weeks (or longer, depending on the treatment) before joining this study.
• People who are pregnant, breastfeeding, or planning to become pregnant at any time from enrolment through to 12 months after the last dose of the study drug.
• People with a known allergy or reaction to any ingredient in the study drug, or who have had a severe allergic reaction (anaphylaxis) to any biological therapy.
• People who have ever received any of the following treatments: alemtuzumab, total lymphoid irradiation, bone marrow transplant, or T-cell vaccination therapy.
• People who have received certain B-cell depleting therapies (such as rituximab or ocrelizumab) within the past 6 months, or within 6–12 months if their B-cell counts have not recovered to normal levels. People who have received certain other immune-modifying biological therapies within the past 6 months are also excluded.
• People who have received certain immune-suppressing drugs (including natalizumab, cyclosporine, methotrexate, mitoxantrone, cyclophosphamide, azathioprine, or mycophenolate mofetil) at therapeutic doses within the 3 months before joining the study.
• People with a history of severe allergic reactions to two or more foods or medicines, including known sensitivity to paracetamol/acetaminophen, antihistamines, or steroids such as methylprednisolone.
• People with a known primary immune deficiency (present from birth or acquired), HIV infection, or who have had their spleen removed, as these conditions increase the risk of serious infection.
• People with an active cancer, or a history of cancer that was active within the past 10 years — with some exceptions, such as certain ovarian tumours, treated skin cancers (squamous cell or basal cell carcinoma with documented successful treatment more than 3 months before joining), or germ cell tumours, subject to review by the study's medical safety team.
• People whose blood test results at screening fall outside certain thresholds for white blood cells, total immunoglobulin, neutrophil count, or CD4 T-cell count (confirm specific values with the trial site).
• People with active hepatitis B or C infection, confirmed by blood testing.
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before the study start date.
• People who have received a BCG vaccine within the past year.
• People with a history of alcohol or drug misuse that, in the investigator's opinion, could affect their safety or ability to attend visits or complete the study.
• People who have had a previous episode of NMDAR encephalitis that recurred within the last 5 years, or who are suspected to have had untreated NMDAR encephalitis lasting more than 3 months at the time of screening.
• People with evidence of active tuberculosis (TB), a high risk of TB based on recent close contact with someone who has active TB, symptoms that could suggest TB, a positive or indeterminate TB test result that has not been addressed with treatment, or lung imaging that suggests possible TB (confirm details with trial site).
• People with an active, clinically significant infection at the time of formal enrolment (though enrolment may be delayed until recovery if still within the screening window).

Additional considerations reviewed on a case-by-case basis (not automatically excluded — confirm with trial site):

• People with certain abnormal liver function test results or low platelet or haemoglobin levels at screening may be reviewed by the study's medical safety team to determine whether participation is appropriate.
• People with a history of untreated hepatitis C, or who are considered cured following antiviral therapy, may be considered for enrolment pending review by the medical safety team.
• People who have additional autoantibodies present alongside NMDAR antibodies may still be considered, subject to review by the medical safety team.

Important: Always verify eligibility with the trial site directly before applying.