Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 female and between 18 and 55 years old
• People who are willing to take part and have signed the study's consent form themselves or through a legal guardian
• People who have been diagnosed with multiple myeloma, confirmed through specific laboratory testing methods (flow cytometry or immunohistochemistry)
• People whose liver is working well enough, based on blood tests showing liver enzyme and bilirubin levels within acceptable ranges (confirm with trial site for exact values)
• People whose kidneys are filtering blood at an adequate rate, based on a calculation using a specific formula (confirm with trial site)
• People whose blood clotting levels fall within acceptable ranges on specific blood tests (confirm with trial site)
• People whose blood counts — including red blood cells, white blood cells, immune cells, and platelets — are at or above the minimum levels required, without having received blood or growth factor support in the week before testing
• People whose heart is pumping blood effectively enough, based on a heart function measurement of at least 45%
• People whose blood oxygen level is at least 92%
• People who are generally able to carry out basic daily activities with little to no limitation (rated 0 or 1 on a standard activity scale used by doctors)
• People whose life expectancy is at least 3 months
• People who are not pregnant and not breastfeeding, and who are willing to use effective contraception for 24 months after receiving the study treatment

Who may not be able to join:

• People who have had an allergic reaction to any ingredient in the type of cell product used in this trial
• People with serious heart conditions, including a heart attack, heart procedure, or stent placement in the past 6 months; unstable chest pain; severe irregular heartbeat; a history of serious non-ischemic heart muscle disease; or significant heart failure
• People who have had a stroke or seizure in the 6 months before joining the trial
• People who have an autoimmune disease, an immune system deficiency, or any condition that requires medication to suppress the immune system
• People who have had another cancer (other than multiple myeloma) in the past 3 years, unless it was a specific type that has been fully treated with no signs of return and no ongoing treatment (confirm with trial site for the list of exceptions)
• People who have an active infection that is not under control
• People with serious unstable conditions affecting the liver, kidneys, or metabolism that require ongoing medication, as assessed by the study doctor
• People who, in the week before the cell collection procedure, have tested positive for hepatitis B virus, hepatitis C virus, HIV, syphilis, or CMV in their blood
• People who have been taking more than 5 mg per day of prednisone (or an equivalent steroid medication) in the week before the cell collection procedure
• People who have previously received any CAR-T cell therapy or other genetically modified T cell treatment
• People who have previously received any treatment specifically targeting a protein called BCMA
• People who have received a live vaccine within 4 weeks before joining the trial
• People with a history of alcohol dependence, drug misuse, or a psychiatric disorder, or anyone the study doctor considers unsuitable for participation

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