Phase 3 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 12 years or older
• People who have been diagnosed with autoimmune encephalitis where the immune system is attacking proteins on the surface of nerve cells
• People who have already tried at least one standard first-line treatment, such as: at least 3 days of high-dose steroid infusions plus intravenous immunoglobulin (IVIG), OR at least 5 sessions of plasma exchange or immunoadsorption, OR at least 2 treatments with a medicine called efgartigimod
• People whose disability is rated at 3 or higher on a standard neurological scale (meaning they need some assistance with daily activities), and whose mental and behavioural symptoms have not improved enough with symptom-relief treatments
• People who have given their own consent to participate, or — for those who cannot consent themselves — whose legal guardian has signed the consent form

Who may not be able to join:

• People who have a serious active infection or a significant ongoing chronic infection, in the opinion of the study doctor
• People who have taken part in another clinical trial using an experimental treatment within the past 4 weeks (or longer, depending on the previous treatment)
• People who are currently pregnant, breastfeeding, or planning to become pregnant at any point from enrolment through to 6 months after the last dose of the study drug
• People with a known allergy to any ingredient in the study drug, or who have had an allergic reaction to any biological treatment in the past
• People whose blood test results at the screening stage fall outside acceptable ranges — this includes abnormal liver enzyme levels, low platelet count, low haemoglobin, low white blood cell count, low immunoglobulin levels, low neutrophil count, or low CD4 T-cell count (confirm specific values with the trial site)
• People who have had a severe allergic reaction (including anaphylaxis) to two or more foods or drugs, including known sensitivity to paracetamol, antihistamines, or steroids such as methylprednisolone
• People with a known history of a primary immune deficiency condition, HIV infection, or removal of the spleen, as these can increase the risk of infection
• People who have received certain immune-suppressing medicines — including natalizumab, cyclosporin, methotrexate, mitoxantrone, cyclophosphamide, or azathioprine — within the 3 months before joining the trial
• People who have received a B-cell depleting experimental treatment, unless their B-cell levels have returned to normal before the trial starts
• People with confirmed active hepatitis B or hepatitis C infection detected through blood testing at screening
• People with a history of cancer, except for certain specific types: ovarian or related teratomas, germ cell tumours, or skin cancers (squamous cell or basal cell carcinoma) that were successfully treated more than 3 months before joining the trial
• People who have received a live or weakened (attenuated) vaccine within 3 weeks before enrolment (inactivated vaccines are acceptable)
• People who have received a BCG vaccine within the past year before enrolment

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