Early Phase 1 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 willing to take part voluntarily, understand what the trial involves, and are able to sign a consent form agreeing to complete all trial procedures.
• People aged 18 or older, of any gender.
• People whose doctors expect them to live for more than 12 weeks.
• People who have been formally diagnosed with multiple myeloma (according to international diagnostic standards updated in 2014) or plasma cell leukaemia (according to the 4th edition of the Chinese haematological disease diagnostic criteria).
• People whose disease shows at least one of the following measurable signs: a certain level of abnormal protein (M protein) in the blood; abnormal protein in the urine (at least 200 mg over 24 hours); abnormally high levels of free light chains in the blood; or at least 10% abnormal plasma cells in the bone marrow (for a specific type of myeloma that does not produce detectable proteins).
• People whose multiple myeloma or plasma cell leukaemia has come back or stopped responding to treatment, and who have already been treated with at least 3 prior treatment regimens that included at least one proteasome inhibitor and one immunomodulatory drug, and whose disease has progressed within 60 days of their most recent treatment or did not reach at least a minimal response.
• People whose kidneys, liver, and heart and lung function meet specific minimum standards set by the trial (confirm with trial site for exact values).
• People whose blood test results meet minimum levels for haemoglobin, white blood cells (neutrophils), and platelets, as assessed by the trial doctors.

Who may not be able to join:

• People who have another cancer that is currently not under control.
• People who test positive for active Hepatitis B virus infection, Hepatitis C virus infection, HIV, or syphilis (based on specific blood test criteria — confirm with trial site for exact thresholds).
• People with unstable or serious heart, blood vessel, liver, kidney, or metabolic conditions, including unstable chest pain, a stroke or mini-stroke within the past 6 months, a heart attack within the past 6 months, severe heart failure, or serious heart rhythm problems requiring medication.
• People whom the trial doctors consider unsuitable for participation for any reason.
• People who are pregnant, breastfeeding, or planning to become pregnant within one year after receiving the cell treatment, or whose male partner plans to father a child within one year after receiving treatment.
• People who have previously received CAR-NK cell therapy or any other gene therapy.
• People who have a condition that affects their ability to understand and sign the consent form, or who are unwilling or unable to follow the study requirements.
• People who have had a severe allergic reaction to any of the drugs used in this trial.
• People who have an active or uncontrolled infection that requires systemic treatment within the 14 days before joining the trial.
• People who, in the past two years, have had organ damage caused by an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus), or who have needed ongoing medication to suppress the immune system or control a systemic disease.
• People who have symptoms affecting the central nervous system (brain and spinal cord).

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