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 aged 18 to 75 years, of any gender
• People who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, based on recognised international diagnostic standards, after receiving at least 3 rounds of treatment (including at least one type from each of two specific drug groups: proteasome inhibitors and immunomodulators), with at least one full cycle completed per round
• People whose myeloma has been confirmed to have worsened during or within 12 months after their most recent myeloma treatment (with no 12-month time limit applied if the last treatment was CAR-T cell therapy)
• People who have at least one measurable sign of the disease at the time of screening, such as certain levels of specific proteins detected in blood or urine tests (confirm with trial site for exact measurements)
• People whose heart, liver, kidneys, and other organs are working well enough to meet the trial's requirements
• People with a physical performance score of 0 or 1 on a standard medical scale (ECOG), meaning they are either fully active or have only mild limits on strenuous activity
• People whose doctors estimate they are likely to survive for at least 12 weeks
• People of childbearing potential, and men whose partners could become pregnant, who agree to use effective contraception throughout the trial and for 12 months after receiving the cell treatment
• People who are willing to take part, sign a consent form, and attend follow-up visits as required

Who may not be able to join:

• People who have a known allergy to any ingredient in the cell product used in this trial
• People who have received CAR-T cell therapy or any other gene-based or similar treatment within 3 months before signing the consent form, unless tests show no detectable CAR-T cells remaining in their body
• People who have plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or a condition called primary light chain amyloidosis
• People who have had any of the following heart or blood vessel conditions in the 6 months before screening: severe heart failure, a specific heart rhythm abnormality present from birth, certain types of abnormal electrical conduction in the heart, a heart attack, unstable chest pain, or procedures such as stent placement or bypass surgery (confirm specific heart conditions with trial site)
• People who have had a stroke or a temporary stroke-like episode (transient ischaemic attack) in the 6 months before screening
• People who have had serious heart rhythm problems requiring treatment in the 6 months before screening
• People with blood pressure that cannot be controlled with medication, or a history of hypertensive crisis or hypertensive brain complications
• People who have had a blood clot in the lungs, a blood clot in the leg veins requiring blood-thinning treatment, or active lung disease or pneumonia in the 6 months before screening
• People who test positive for active Hepatitis B, Hepatitis C, or syphilis infections, based on specific blood test combinations (confirm exact criteria with trial site)
• People with known lupus, active or uncontrolled autoimmune diseases (such as Crohn's disease or rheumatoid arthritis), or conditions affecting the immune system such as HIV infection or severe ongoing infections
• People who have or have had another cancer that is not well controlled or not considered cured, except for certain cancers that have been fully treated with no recurrence, such as some skin cancers, early-stage cervical cancer, or other specific cancers with no recurrence for at least 5 years (confirm with trial site)
• People with a current or past history of significant brain or nervous system conditions, such as epilepsy, stroke, severe brain injury, paralysis, dementia, Parkinson's disease, or serious mental illness
• People whose myeloma has spread to the central nervous system (the brain or spinal cord), or who have symptoms suggesting this may have occurred
• People who have received a donor organ transplant or bone marrow transplant from another person within 6 months before screening, or a stem cell transplant using their own cells within 3 months before the blood collection procedure
• People who have active graft-versus-host disease (a complication that can follow certain transplants) at the time of screening
• People who have received certain myeloma treatments too recently before the blood collection procedure, including immunosuppressants or radiation within 2 weeks, certain chemotherapy or targeted drugs within 2 weeks or 3 half-lives (whichever is shorter), certain antibody-based therapies within 4 weeks or 3 half-lives (whichever is shorter), or immunomodulator drugs within 1 week (confirm with trial site)
• People who have received a live vaccine within 4 weeks before signing the consent form
• People with a history of serious mental illness or substance misuse
• People who are pregnant or breastfeeding
• People currently taking part in another interventional clinical trial who have not completed the required washout period before the blood collection procedure
• People who the trial investigators consider unsuitable for other reasons that could affect their safety or ability to complete the trial

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