Phase 2 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 have been diagnosed with active multiple myeloma, confirmed by specific blood or urine test results showing measurable levels of abnormal proteins (confirm with trial site for exact thresholds).
• People who have already gone through at least 3 previous rounds (lines) of treatment for multiple myeloma.
• People whose previous treatments included all three of the following types: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody — these are specific categories of myeloma medicines (confirm with trial site if unsure which medicines count).
• People whose myeloma has been confirmed to be getting worse (progressing) either during or within 12 months after their most recent myeloma treatment.
• People aged 18 to 75 years old (inclusive).
• People who are generally well enough to carry out normal daily activities, with a fitness score of 0 or 1 on a standard medical scale used by doctors (ECOG score).
• People with an estimated life expectancy of at least 3 months.
• People whose blood counts, liver function, kidney function, heart function, and oxygen levels all meet specific minimum thresholds as measured by tests during screening (confirm with trial site for exact values).
• People who are able and willing to attend all required study visits and follow study procedures.
• People with enough accessible veins suitable for a blood cell collection procedure called leukapheresis.
• Women who could become pregnant must have a negative pregnancy test before starting treatment, must agree to use two forms of contraception for at least 1 year after receiving the study treatment, and must agree not to breastfeed for at least 1 year after receiving the study treatment.
• Men must agree to use a condom during sexual contact with women who are pregnant or who could become pregnant for at least 2 years after receiving the study treatment, even if they have had a vasectomy.
• People who have read and voluntarily signed a consent form agreeing to take part.

Who may not be able to join:

• People who have previously received any CAR-T cell therapy.
• People who have received high-dose steroid medicines (equivalent to 70 mg or more of prednisone) within the 7 days before the cell collection procedure.
• People who, in the doctor's judgment, will need ongoing high-dose steroids or other immune-suppressing medicines during the 12 weeks after starting study treatment.
• People who have received a live vaccine within 4 weeks before the cell collection procedure.
• People who have received any cancer treatment (including radiation, chemotherapy, or targeted therapy) within 14 days before the cell collection procedure (a limited exception may apply for certain small areas of radiation — confirm with trial site).
• People who have received a monoclonal antibody treatment for myeloma within 21 days before the cell collection procedure.
• People who take daily steroid medicines at doses above what the body naturally produces (for example, prednisone at 7.5 mg per day or more).
• People with certain serious heart conditions, including moderate-to-severe heart failure, a heart attack or heart bypass surgery within the past 6 months, significant abnormal heart rhythms, unexplained fainting episodes, or a history of severe heart muscle disease.
• People who need help with breathing through a machine or oxygen support, or whose blood oxygen level at rest is below 95% (a limited exception may apply if lung function tests meet specific thresholds — confirm with trial site).
• People with high blood pressure that cannot be controlled with medication.
• People who have had significant bleeding, a blood clotting disorder, a stroke, a deep vein blood clot, or a pulmonary embolism within a specific recent time period before screening.
• People who have another active, uncontrolled cancer (certain early-stage or fully treated skin cancers and similar low-risk conditions may be exceptions — confirm with trial site).
• People who received a stem cell transplant using someone else's cells within 6 months before the cell collection procedure, or who still have signs of graft-versus-host disease.
• People who received a stem cell transplant using their own cells within 12 weeks before the cell collection procedure.
• People with an active serious infection (viral, bacterial, or fungal) that requires treatment.
• People with an active autoimmune disease, or a history of autoimmune disease within the past 3 years.
• People with significant signs of dementia, serious mental health conditions, or a history of neurological conditions such as epilepsy, stroke, Parkinson's disease, or severe brain injury.
• People whose myeloma has spread to the brain or spinal fluid.
• People who test positive for HIV, active Hepatitis B, active Hepatitis C, or syphilis.
• People with certain related blood or plasma cell conditions, including plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary amyloidosis.
• People with a history of severe allergic reactions, or who are allergic to any ingredient in the study treatment or the preparatory medicines used before infusion.
• People who have planned surgery within 2 weeks before the cell collection procedure or during the study (minor procedures under local anaesthetic may be exceptions — confirm with trial site).
• People who are pregnant, breastfeeding, or planning to become pregnant during or within 2 years of treatment.
• People who still have significant side effects from previous cancer treatments that have not returned to a mild level.
• People who have taken part in another clinical trial within 4 weeks before signing the consent form, or within a specific time period based on the last medicine taken in that trial (whichever is longer).
• People for whom the treating doctor believes trial participation would not be in their best interest, or whose situation might make it difficult to complete the trial safely.

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