Phase 1 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 are between 18 and 65 years old at the time of their screening visit.
• People who have been diagnosed with multiple sclerosis (MS) according to a specific set of medical guidelines called the 2017 McDonald Criteria.
• People whose MS has been identified as the progressive type, based on a specific classification system from 2014.
• People who either have evidence of past chickenpox infection (through a blood test showing antibodies) or have received at least one dose of the Shingrix shingles vaccine at least four weeks before treatment begins.
• People who have evidence of past Epstein-Barr virus (EBV) infection, shown by a blood test.
• People whose blood counts and organ function fall within acceptable ranges, including healthy enough levels of white blood cells, platelets, immune proteins, red blood cells, and kidneys, liver, lungs, and heart working well enough to meet specific measured thresholds (confirm with trial site).
• People who have completed a specific set of blood tests for infectious diseases, including HIV, hepatitis B and C, syphilis, HTLV, herpes, chickenpox, and cytomegalovirus, and who test negative for HIV, HTLV, syphilis, and hepatitis C, among others.
• Women who could become pregnant must have a negative pregnancy test before joining.
• People who are willing and able to use highly effective birth control for the entire study period, which extends 12 months after receiving the treatment.
• People who are able to understand the study information and are willing to sign a written consent form.
• People whose vital signs fall within acceptable ranges, including blood pressure, heart rate, temperature, and breathing rate, at the time of screening.

Who may not be able to join:

• People who have a diagnosis of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody-associated disease (MOGAD), which are conditions sometimes confused with MS.
• People who have taken part in another clinical trial and received an experimental treatment within the past 3 months (or longer, depending on the treatment), unless that treatment was approved for COVID-19 prevention or treatment.
• People who start a new MS disease-modifying treatment after their blood collection procedure (apheresis) and before the chemotherapy phase of this trial begins.
• People who have a history of a tumour in the brain or spinal cord, or another progressive neurological condition unrelated to MS, or conditions such as sarcoidosis that could affect the study assessments.
• People with a history of a bone marrow disorder called myelodysplastic syndrome (MDS).
• People with a history of sickle cell anaemia or other inherited disorders affecting red blood cells.
• People with abnormal blood clotting results, or who have certain antibodies associated with clotting disorders (such as antiphospholipid antibodies or lupus anticoagulant).
• People who have an active, uncontrolled infection, or who have needed hospital treatment or intravenous antibiotics for an infection within the past 4 weeks (minor infections that are responding to treatment may be acceptable — confirm with trial site).
• People with a psychiatric condition or difficult personal circumstances that the trial team believes would put them at unacceptable risk.
• People with a history of liver cirrhosis (severe liver scarring).
• People with a history of cancer, other than certain minor skin cancers or early-stage cancers that were fully treated, unless they have been cancer-free for at least 3 years.
• People with an active HIV, hepatitis B, or hepatitis C infection (a past infection that has been fully cleared may be acceptable — confirm with trial site).
• People with a brain or nervous system condition unrelated to MS, such as a history of stroke, dementia, or cerebellar disease, that could make it hard to assess the safety of the treatment.
• People who have had a heart attack, heart procedure, or significant uncontrolled heart disease within the past 4 months.
• People who are currently taking blood-thinning medications or antiplatelet drugs.
• People with a history of Crohn's disease, rheumatoid arthritis, or lupus that required ongoing immune-suppressing treatment within the 2 years before joining the trial.
• People with a primary immune deficiency disease.
• People who, in the investigator's judgement, are unlikely to be able to complete all required study visits and follow-up.
• People who have had a severe allergic reaction to any of the medications used in this study, including the CAR T cell treatment (KYV-101), a preservative called dimethyl sulfoxide, the chemotherapy drug bendamustine, or a drug called tocilizumab.
• People with any other medical condition that the investigator believes could interfere with the study results or safety.
• People who have previously received a type of radiation therapy called total lymphoid irradiation, or the drug mitoxantrone above a certain cumulative dose.
• People who have previously had a stem cell transplant, CAR T cell therapy, or gene therapy of any kind.
• People who received certain MS treatments too recently — specific waiting periods apply depending on the medication (confirm with trial site for the exact washout period required for each drug).
• People who have previously had an organ transplant (such as a kidney or liver transplant).
• People with significant heart problems, including recent heart attack or bypass surgery, severe heart failure, serious heart rhythm problems, severe heart muscle disease, poor heart pumping function, or active heart complications from lupus.
• People who have previously had their spleen removed.
• People with moderate or severe asthma or chronic obstructive pulmonary disease (COPD).
• People with a specific abnormality in the heart's electrical activity (called a prolonged QTc interval), measured on an ECG.
• People with heart valve problems, including leaking, narrowing, or absent valves.
• People with moderate or worse kidney impairment, based on a measure of how well the kidneys filter the blood (confirm with trial site for exact thresholds).
• People who received the MS drug Mavenclad (cladribine) and have not yet completed a required 9-month washout period.
• People with a history of seizures or epilepsy, even if their seizures are currently well controlled with medication.
• People who have previously received any CAR T cell therapy or gene therapy directed at any target.

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