Phase 2 Brain Cancer 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 aged 14 years or older, of any sex
• People whose autoimmune encephalitis symptoms started no more than 9 months before joining the trial
• People diagnosed with autoimmune encephalitis, meaning they had a rapid onset (within 3 months) of at least four of these six symptoms: unusual behaviour or memory/thinking problems; speech difficulties such as speaking urgently, very little, or not at all; seizures; abnormal movements or muscle stiffness; reduced consciousness; or problems with automatic body functions (like breathing or heart rate)
• People whose diagnosis is confirmed by a positive anti-NMDAR (GluN1) IgG antibody found in spinal fluid, or a positive LGI1 antibody found in blood and/or spinal fluid
• People whose diagnosis cannot be explained by another condition or a different type of brain inflammation
• People whose autoimmune encephalitis has not responded to standard treatments (steroids and rituximab or other immune-suppressing medicines), and who still have significant disability after treatment — OR people whose condition has relapsed (new or worsening symptoms at least 2 months after first- or second-line treatment)
• People whose doses of steroids and other immune-suppressing medicines have been stable for at least 4 weeks before joining
• People (or their legal representative) who are able to give consent to participate
• Women who could become pregnant must use effective contraception during the trial and for at least 3 months after the last dose of the study drug

Who may not be able to join:

• People with a history of certain other autoimmune conditions, such as lupus, rheumatoid arthritis, or Sjögren's syndrome (thyroid conditions alone do not automatically exclude someone — confirm with trial site)
• People with certain abnormal blood or organ test results, including low white blood cell, neutrophil, haemoglobin, or platelet counts, or raised levels indicating reduced kidney, liver, or muscle function (confirm specific thresholds with trial site)
• People with signs of an active infection such as shingles, HIV, or active tuberculosis
• People with active hepatitis or a history of severe liver disease; people who test positive for hepatitis B surface antigen, or who test negative for that marker but positive for hepatitis B core antibody with detectable hepatitis B virus in the blood; or people who test positive for hepatitis C antibodies
• People with uncontrolled diabetes, indicated by a glycosylated haemoglobin level above 9.0% or a fasting blood sugar of 11.1 mmol/L or higher
• People who received a live vaccine within 3 months before joining, or who plan to receive any vaccine during the study
• People who received rituximab or another biological therapy within 1 month before joining
• People with a current or past cancer diagnosis
• People with a known allergy to human biological products
• People who have taken part in another clinical trial within 28 days before joining, or within a period equal to five times the half-life of that trial's study drug
• People who are pregnant, breastfeeding, or planning to have children during the trial
• People with known alcohol or drug misuse that could affect their ability to follow the trial requirements
• People considered unsuitable for the trial by the investigating doctor, such as those with severe mental health conditions

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