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 aged 18 or older who are able to understand the study and are willing to sign a consent form
• People with a general health and activity level rated 0, 1, or 2 on a standard scale used by doctors to measure how much cancer affects daily functioning (confirm with trial site)
• People with a life expectancy of more than 12 weeks
• People who have a confirmed diagnosis of multiple myeloma that has come back or stopped responding to treatment, with measurable signs of disease in the blood, urine, bone marrow, or immune proteins
• People whose multiple myeloma has been treated with at least 3 prior treatment courses — including one from each of three specific drug types: a proteasome inhibitor, an IMiD (a type of immune-modifying drug), and an anti-CD38 antibody — or whose disease has stopped responding to all three of these drug types
• People whose heart, lung, kidney, liver, and blood counts meet certain minimum levels required for safe participation (confirm specific values with trial site)
• People whose side effects from previous cancer treatments have mostly resolved, with only minor ongoing issues allowed (such as mild hair loss or mild nerve-related symptoms)
• People who have had or currently have another type of cancer, as long as that cancer and its treatment are unlikely to interfere with this study
• People who are willing and able to use highly effective contraception before, during, and for 6 months after receiving the study treatment — acceptable methods include complete abstinence, surgical sterilisation, an intrauterine device (IUD), or a combination of hormonal contraception and barrier methods
• People who are willing and able to follow all study procedures, including a long-term safety follow-up period of up to 15 years as required by the FDA

Who may not be able to join:

• People who have received treatment for multiple myeloma within 14 days before the scheduled cell collection procedure (leukapheresis), unless the medical team has specifically approved this
• People who have been taking high-dose steroids or other immune-suppressing medicines within 14 days before cell collection
• People who have had an autologous (using their own cells) stem cell transplant within the 3 months before cell collection
• People who have ever had an allogeneic (using another person's cells) stem cell transplant
• People who have received another CAR-T cell therapy within 6 months before cell collection
• People who have or have had plasma cell leukaemia (a specific and aggressive form of blood cancer)
• People whose myeloma has spread outside the bone marrow but does not meet the measurable disease requirements listed in the inclusion criteria
• People who have received a type of treatment called a bispecific T cell engager within 6 months before cell collection
• People who have received a drug called bendamustine within 6 months before cell collection
• People whose only disease is a single tumour mass (solitary plasmacytoma) with no other measurable disease present
• People who have had allergic reactions to treatments that are chemically or biologically similar to CAR-T cell therapies
• People who cannot tolerate the specific preparation chemotherapy drugs (fludarabine or cyclophosphamide) used in this study
• People who still have significant side effects (above a minor level) from previous cancer treatments, with the exception of mild hair loss or mild nerve symptoms
• People with an active bacterial, viral, or fungal infection that requires treatment with medicines
• People with symptomatic heart failure
• People who have had unstable chest pain, a serious heart rhythm problem, or a heart attack within the 6 months before joining the study
• People with significant lung problems affecting normal breathing
• People with an autoimmune disease that requires immune-suppressing treatment
• People who have had a blood clot in the lungs (pulmonary embolism) or legs (deep vein thrombosis/DVT) within 3 months of joining the study, or whose clotting condition is not well controlled (people with a history of DVT or PE more than 3 months ago who are on stable blood-thinning medication may still be eligible — confirm with trial site)
• People who have had a serious bleeding event within the past 60 days
• People with active hepatitis B or hepatitis C infection, or HIV (people with a past history of hepatitis B or C who have completed antiviral treatment and have shown no detectable virus for 6 months may still be eligible — confirm with trial site)
• People with active cancer involvement in the brain or spinal cord (people who have been treated for this and have no symptoms may be considered — confirm with trial site)
• People with a history of certain brain or nervous system conditions, including epilepsy, seizures, stroke, brain bleeds, serious brain injury, dementia, Parkinson's disease, or psychosis
• People who have an active cancer other than myeloma that has needed treatment in the last 3 years or is not fully in remission (some exceptions may apply for certain skin cancers or prostate cancer not requiring treatment — confirm with trial site)
• People who are pregnant or breastfeeding, or people of childbearing potential who are not using effective contraception
• People with a significant medical condition, abnormal test results, or a psychiatric illness that would make safe participation or proper data collection difficult
• People taking other medicines that may interfere with the study (the treating doctor would need to review this)

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