Early Phase 1 Transverse Myelitis 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:

• You are between 18 and 75 years old (inclusive)
• You have been diagnosed with one of the following conditions that has not responded well to standard treatments: a specific type of optic neuromyelitis (AQP4-positive NMOSD), myasthenia gravis (MG), chronic inflammatory nerve disorder (CIDP), inflammatory muscle disease (IIM), progressive or relapsing multiple sclerosis (PMS or RMS), POEMS syndrome, autoimmune encephalitis, or a condition called MOGAD — and your condition meets specific disease activity and treatment history requirements for each (confirm with trial site)
• You have had previous treatments that did not work well enough, or you were unable to tolerate them, depending on your specific diagnosis
• Your blood counts are at an acceptable level — including enough white blood cells, platelets, and red blood cells
• Your liver is working well enough, based on blood test results
• Your kidneys are working well enough, based on a specific calculation of kidney function
• Your blood electrolyte levels (such as potassium, calcium, and magnesium) are within acceptable ranges
• Your blood clotting function is within acceptable ranges
• Your blood oxygen level is above 91% while at rest
• A heart scan (echocardiogram) shows your heart is pumping adequately
• Your doctor expects you to live for at least 12 more weeks
• You and your partner are willing to use reliable contraception for at least one year after receiving the cell treatment
• You are willing and able to give written consent to participate

Who may not be able to join:

• Your blood does not contain enough of a specific type of cell needed to make the CAR-T cell treatment
• You have a history of a condition where your immune system attacks your own red blood cells (autoimmune hemolytic disease)
• You have previously had an organ transplant
• You received a drug called alemtuzumab within the last 6 months, or fludarabine or cladribine within the last 3 months
• You have an active infection with a type of virus called Papovavirus
• You have been diagnosed with cancer in the last 2 years (some early-stage or fully treated cancers may be exceptions — confirm with trial site)
• You currently have an active or ongoing infection with hepatitis B, hepatitis C, HIV, CMV, or syphilis
• You have myasthenia gravis and your symptoms were not under control in the 2 weeks before joining
• You have a known history of a primary immune system deficiency (a condition where your immune system does not work properly from birth or developed over time)
• You have serious heart problems, such as unstable chest pain, a heart attack within the last 6 months, severe heart failure, or serious irregular heartbeat
• You have had a stroke or mini-stroke (TIA) within the last 6 months
• You have had a major surgery within the last 4 weeks
• You have another serious or uncontrolled health condition that could interfere with the study, in your doctor's opinion
• You had your thymus removed within the last 12 months
• You have a history of substance abuse that has not been resolved, or a history of serious psychiatric illness
• You have a history of serious allergies or are known to be prone to severe allergic reactions
• You are pregnant or currently breastfeeding
• Your doctor decides there is another reason you should not participate

Additional checks before receiving the actual cell treatment:

• Your blood counts must still be at an acceptable level just before the treatment is given
• You must be able to maintain your blood oxygen level without needing extra oxygen
• You must not have new serious medical problems at that time, such as uncontrolled irregular heartbeat, very low blood pressure, an active serious infection requiring IV antibiotics, or reduced kidney function
• You must not need special medical support in the week leading up to the treatment
• The cell infusion must not be delayed more than 7 days after the preparation treatment (lymphodepletion)

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