Phase 2 Multiple Sclerosis 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 enrolled in and fully completed a previous study called TILS-021 within the last 90 days, including all required end-of-treatment and end-of-study visits.
• People whose recent blood test results fall within acceptable ranges as determined by the study doctor.
• People with adequate blood counts without needing regular blood transfusions (specifically, haemoglobin of at least 9 g/dL and platelets of at least 100 x 10⁹ cells/L).
• People whose kidney function tests are within acceptable limits (creatinine no more than 1.5 times the upper limit of normal, or a calculated kidney clearance rate of at least 60 mL/min).
• People whose liver function tests are within acceptable limits (total bilirubin no more than 1.5 times the upper limit of normal, unless due to a condition called Gilbert's disease; and liver enzyme levels — ALT and AST — no more than twice the upper limit of normal).
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose of study treatment.
• Sexually active women who could become pregnant, and male participants, must agree to use two effective forms of contraception throughout the study and for 90 days after treatment ends.
• People whose vaccinations are current and up to date, taking into account their condition and any treatments they have had, as confirmed by their treating neurologist.
• People who are willing and able to give written consent to participate.

Who may not be able to join:

• People who left the previous TILS-021 study early and did not complete the required end-of-treatment or end-of-study visits.
• People who withdrew from TILS-021 because of side effects or adverse events.
• People who have used steroid medications (oral or intravenous) in the past 60 days, or who are expected to need them during the study.
• People who are currently using, or have used within the past 30 days, certain immune-modifying or immunosuppressant medications (such as interferon, glatiramer acetate, fingolimod, natalizumab, methotrexate, and several others — confirm the full list with the trial site).
• People who are expected to need to start or stop other MS medications during the study, including a group of treatments that target B cells (such as ocrelizumab, ofatumumab, ublituximab, or rituximab).
• People who used B cell-depleting therapies at any point during or after the TILS-021 study.
• People who have ever been treated with alemtuzumab, cyclophosphamide, cladribine, mitoxantrone, or daclizumab.
• People who have previously had a stem cell transplant or stem cell therapy.
• People who have used nasal corticosteroids, nasal antihistamines, or nasal flu treatments in the past 60 days.
• People with an active COVID-19 infection, as defined by FDA guidelines.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study. A pregnancy test will be required at several points, and participation would be stopped if a test returns a positive result.
• People with any history of cancer, including any type of skin cancer at any time.
• People with certain autoimmune or inflammatory conditions, including inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, or type 1 diabetes.
• People who are allergic to gadolinium (a contrast dye used in MRI scans), have metal implants, severe chronic kidney disease (eGFR below 30 mL/min), claustrophobia, or who are unable to lie flat in an MRI or PET scanner for the required time.
• People known to be positive for HIV, hepatitis B, hepatitis C, or tuberculosis — including those with a past history of these conditions, even if current tests are negative.
• People with significant nasal conditions such as a severely deviated septum, nasal polyps, chronic rhinitis, or sinusitis diagnosed or treated in the past 12 months.
• People with significant heart conditions or abnormal heart readings (ECG) at the time of screening or by medical history. Heart readings will be checked before each treatment cycle and participation may be stopped if an abnormality is found.
• People with any other medical condition or situation that, in the study doctor's opinion, could affect their ability to follow the study requirements or affect the reliability of the results.
• People who have taken part in another clinical trial or received another experimental treatment within the past 30 days, or who are currently receiving another experimental treatment alongside this study.

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