Phase 1 Myeloma 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:

• Adults aged 18 or older, of any gender
• People with a confirmed diagnosis of multiple myeloma who meet at least one of the following: the disease has come back or not responded well after at least 2 previous standard treatments; the disease came back within 18 months of first-line treatment; or the disease has features linked to a high risk of returning or getting worse (such as certain genetic markers)
• People with at least one measurable sign of the disease, such as specific protein levels in the blood or urine, or abnormal protein levels in the blood (confirm with trial site for exact measurements)
• People with no signs of the myeloma spreading to soft tissues outside the bone marrow
• People who are reasonably well and able to carry out daily activities — rated 0, 1, or 2 on a standard health performance scale (confirm with trial site)
• People with a life expectancy of at least 3 months
• People whose bone marrow is producing enough blood cells, based on blood tests taken within the month before screening (including adequate red blood cells, white blood cells, platelets, and certain immune cells)
• People whose kidneys, liver, heart, and lungs are functioning at an adequate level, based on tests taken within the month before screening
• Women who could become pregnant must have a negative pregnancy test before joining and must not be breastfeeding during the study
• People who are able to have children (male or female) must agree to use reliable contraception from the time of signing the consent form until one year after the last dose, and must agree not to donate sperm or eggs during this period
• People who have signed an informed consent form (or whose legal representative has done so), showing they understand and voluntarily agree to take part

Who may not be able to join:

• People who have previously received CAR-T cell therapy or any other gene-modified cell therapy
• People who have active involvement of the cancer in the brain, spinal cord, or nervous system at the time of screening, or who have other significant nervous system conditions
• People who have received certain anti-cancer treatments too recently before the study infusion — including chemotherapy or other systemic treatments within 14 days (or within a set number of half-lives of the drug), radiation to non-bone-marrow areas within 7 days, radiation to bone marrow areas within 14 days, or a specific type of myeloma-targeted antibody therapy (BCMA-targeting) within 3 months
• People with an active or uncontrolled infection that requires ongoing systemic treatment at the time of screening
• People with significant heart problems, including severe heart failure, a heart attack or heart surgery within the past 6 months, serious irregular heartbeat, unexplained fainting episodes, or a history of severe non-ischemic heart muscle disease
• People with certain other serious health conditions, including a primary immune system disorder, a stroke or seizure within the past 6 months, significant cognitive impairment or serious psychiatric conditions, or Parkinson's disease or similar movement disorders
• People who have had a moderate to severe immune reaction related to a stem cell transplant (called graft-versus-host disease) within the past 4 weeks
• People with a history of another cancer, unless it was fully treated with no known active disease for at least 2 years, or was a specific type of early-stage or localised cancer that was fully treated (confirm with trial site for details)
• People who received a live vaccine within 4 weeks before screening
• People with a known severe allergic reaction to the study treatment or any of its ingredients
• People for whom a suitable vein cannot be found for intravenous access
• People whom the trial doctors consider unsuitable for any other reason

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