Early 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:

• People who are willing to give their agreement in writing to take part and are able to follow all study requirements
• People aged 18 to 75 years, of any gender
• People who have been diagnosed with active multiple myeloma (a type of blood cancer) according to international diagnostic standards
• People who have previously had a stem cell transplant, or who have been assessed as not suitable for one
• People who have received at least two previous rounds of treatment for multiple myeloma, including specific drug types (medicines that modify the immune system, medicines that block protein breakdown in cells, and a therapy targeting a protein called CD38) — and whose disease has come back or got worse after the last treatment, or who had to stop treatment permanently due to side effects (confirm with trial site)
• People whose bone marrow sample tests positive for a specific protein called BCMA on the surface of the cancer cells
• People who have measurable signs of disease at the time of screening, based on bone marrow tests, specific protein levels in the blood or urine, or visible new or growing lesions (confirm with trial site for specific measurements)
• People whose general health and ability to carry out daily activities is rated at a mild to moderate level on a standard medical scale (ECOG score of 0, 1, or 2)
• People whose expected survival is at least 12 weeks
• People whose blood, liver, kidney, heart, and clotting test results meet specific minimum levels before joining (confirm with trial site for exact values)
• People (and their partners) who agree to use effective contraception from the time of signing consent until one year after receiving the treatment

Who may not be able to join:

• People with a history of a complication called graft-versus-host disease, or who have an autoimmune condition, immune deficiency, or any condition that requires long-term immune-suppressing medication
• People who have had a donor stem cell transplant within 6 months before the treatment infusion, or their own stem cell transplant within 3 months before the infusion
• People who have received certain recent cancer treatments within specified time periods before joining, including antibody therapies, chemotherapy, targeted drug therapies, experimental treatments, radiotherapy, or other anti-cancer treatments (confirm with trial site for exact timeframes)
• People who have taken high-dose steroid medicines (above a certain daily amount) within 7 days before screening, with some exceptions such as low-dose or inhaled steroids
• People with blood pressure that cannot be brought under control with two or more blood pressure medicines, or with persistently low blood pressure despite treatment
• People with serious heart conditions, including unstable chest pain, a heart attack within the past 6 months, significant heart failure, or serious irregular heart rhythms
• People with severe ongoing conditions affecting the liver, kidneys, breathing, or metabolism that require ongoing medication
• People who have been diagnosed with another cancer within the past 5 years, apart from certain early-stage or fully treated cancers such as some skin cancers, early cervical changes, or certain breast or prostate cancers treated with surgery
• People who have previously had an organ transplant (such as a kidney or liver transplant)
• People whose multiple myeloma has spread to the central nervous system (the brain or spinal cord), or who have related symptoms
• People whose myeloma has spread to tissues well outside the bone marrow, except in one specific limited situation (confirm with trial site)
• People with a related condition where a high proportion of plasma cells are circulating in the blood (plasma cell leukaemia)
• People who have had major surgery within 2 weeks before treatment, or who have planned major surgery within 2 weeks after treatment (minor surgery under local anaesthetic may be acceptable — confirm with trial site)
• People who have taken part in another experimental drug trial within 1 month before signing the consent form
• People who have an active, uncontrolled infection within 7 days before the treatment infusion
• People who test positive for certain infectious diseases including active hepatitis B, hepatitis C, HIV, cytomegalovirus (CMV), or syphilis
• People who are pregnant or breastfeeding
• People with a psychiatric illness, altered consciousness, or certain nervous system conditions
• People who still have significant side effects from previous cancer treatment that have not returned to near-normal levels
• People who, in the treating doctor's assessment, have any other condition that makes participation unsuitable

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