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 or older
• People who have multiple myeloma that has come back or stopped responding to treatment
• People whose myeloma produces measurable proteins in the blood at levels that meet specific thresholds (confirm with trial site)
• People who have already received at least 3 different treatment regimens, including specific types of drugs known as proteasome inhibitors, immunomodulatory drugs (IMiDs), and anti-CD38 antibody treatments
• People whose myeloma did not respond well enough to their most recent treatment, or came back within a certain timeframe after it
• People who have previously had a stem cell transplant, or who have been assessed as not suitable for one
• People whose general health and ability to carry out daily activities meets a specific fitness standard (ECOG score of 0 or 1 — confirm with trial site)
• People whose kidney function, blood cell counts, and other blood measures meet minimum required levels (confirm with trial site for specific values)
• People who weigh more than 30 kg
• People who agree to pregnancy testing and to use adequate contraception if applicable
• People who provide written informed consent to participate

Who may not be able to join:

• People who have been diagnosed with a condition called systemic light chain amyloidosis
• People who have previously received any gene therapy or cell therapy, whether as part of a trial or as an approved treatment
• People who received an allogeneic (donor) stem cell transplant within the past 12 months
• People who have moderate or severe chronic graft-versus-host disease (a complication of donor stem cell transplants) that requires ongoing medication or steroids
• People whose blood oxygen level is at or below 90% when breathing normal air
• People who have significant heart disease that is not well controlled, or who have had a serious heart event in the past 6 months
• People whose heart pumping function is below a certain level on a heart scan (confirm with trial site)
• People who have an abnormal heart rhythm measurement on an ECG that exceeds a specific threshold (confirm with trial site)
• People who have an uncontrolled irregular heartbeat (note: people with atrial fibrillation that is well controlled with medication are not automatically excluded — confirm with trial site)
• People who have a history of blood clots in the veins or lungs and are still receiving blood-thinning medication at the time of a specific stage of the trial
• People whose kidneys are so impaired that they require dialysis
• People with significant liver disease, including abnormal liver blood test results above certain levels, or signs of advanced liver failure — except in some cases where a specific inherited condition called Gilbert's syndrome is present
• People who have had a major surgical procedure in the past 3 months (note: certain minor spinal procedures for bone pain are permitted)
• People who have active bleeding in the digestive system
• People who have an active bacterial or viral infection currently requiring treatment
• People who have myeloma affecting the brain or nervous system, or who have certain significant neurological conditions such as recent stroke (within 3 months), epilepsy, severe brain injury, dementia, Parkinson's disease, or uncontrolled psychiatric illness
• People who are taking corticosteroid medication at a dose higher than 5 mg of prednisolone per day (or equivalent) and are unable to stop
• People with an active autoimmune disease that requires immune-suppressing medication
• People with a past or current history of any other cancer (confirm with trial site)
• People who have received radiotherapy within the 7 days before certain trial procedures (note: targeted radiation to a single area for bone pain may be permitted at any time)
• People who have received any myeloma treatment within the 7 days before certain trial procedures
• People who are unable to tolerate the blood collection procedure (leukapheresis) used to collect cells for this therapy
• People with a life expectancy of less than 3 months
• People who are pregnant or breastfeeding
• People with a known allergy to albumin or DMSO (a substance used in the treatment preparation)

Additional criteria that apply specifically at the time of the CAR-T cell infusion stage:

• People who have an active infection requiring treatment, or who have had a temperature of 38°C or higher within 48 hours before the scheduled infusion
• People who require supplementary oxygen at the time of the scheduled infusion
• People whose liver or kidney function has declined significantly since joining the trial

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