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 who have signed the study's official consent form
• People aged 18 or older at the time of signing the consent form
• People whose general physical functioning is rated at a level that allows them to care for themselves and be up and about for at least half of waking hours, as assessed by their doctor (confirm with trial site)
• People whose doctor estimates they have a life expectancy of at least 3 months
• People who have been diagnosed with a specific type of multiple myeloma called "kappa-restricted relapsed or refractory multiple myeloma," confirmed by a specialised bone marrow test called flow cytometry
• People who have already received at least two previous treatment courses for their myeloma, including one from a class of drugs called proteasome inhibitors and one from a class called immunomodulatory drugs, and whose myeloma has come back or stopped responding after the most recent treatment
• People whose myeloma can be measured through specific blood or urine protein tests, or in some cases through bone scan results showing ongoing disease
• People whose last treatment with certain chemotherapy types or antibody-based therapies was at least 4 weeks ago, and whose stem cell transplant (if they had one) was at least 12 to 24 weeks ago, depending on the type
• People whose blood counts (red blood cells, white blood cells, immune cells, and platelets) meet the minimum levels required, as tested within 7 days before joining
• People whose heart function shows the heart pumping at least 40% of its normal capacity, confirmed by a heart scan taken within 90 days before joining
• People whose blood oxygen level is at least 90% while breathing normal room air
• People whose kidneys are functioning at an adequate level, confirmed by blood or urine tests within 7 days before joining
• People whose liver is functioning at an adequate level, confirmed by blood tests within 7 days before joining
• People who are taking no more than 20 mg per day of the steroid prednisone (or an equivalent dose of a similar steroid)
• Women who could become pregnant and men who have partners who could become pregnant, who agree to use highly effective contraception from enrolment until at least 2 months after receiving the study treatment (or longer if the treatment cells are still detectable)
• Women who could become pregnant who have a negative pregnancy blood test within 3 days before joining
• Sexually active male participants who agree to use a condom during intercourse and to avoid donating sperm from enrolment until at least 52 weeks after receiving the study treatment

Who may not be able to join:

• People whose myeloma is "lambda-restricted" rather than "kappa-restricted"
• People who have certain related blood or plasma cell conditions, including plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
• People who have, or have had in the past, myeloma affecting the brain or spinal cord, or who show signs of this
• People who have had major surgery within the 4 weeks before joining
• People who have received a live vaccine (other than a COVID-19 vaccine) within 4 weeks before the planned start of the pre-treatment conditioning chemotherapy
• People who have received another experimental treatment very recently (within 30 days, or within 5 half-lives of that treatment, whichever is shorter) before the planned cell collection procedure
• People who have significant heart problems, such as uncontrolled irregular heartbeat, heart failure, or a heart attack within the past 6 months, or who have severe heart disease as classified by medical guidelines
• People who have significant neurological conditions, such as uncontrolled seizures, severe brain injury, dementia, Parkinson's disease, or certain inflammatory nerve conditions (note: people with a seizure disorder who have been seizure-free for 12 months without changes to their medication may still be eligible — confirm with trial site)
• People who currently have or have had another active cancer, unless it was a low-risk or early-stage cancer that has been fully treated with no signs of return for at least 2 years
• People with an active HIV infection, or active hepatitis A, B, or C infection (some people with prior hepatitis B or C exposure may still be eligible — confirm with trial site)
• People who have another significant active infection confirmed by tests or imaging
• People who have a known autoimmune disease or another condition that requires ongoing immune-suppressing treatment (other than low-dose steroids up to 20 mg per day of prednisolone or equivalent)
• People who currently have active graft-versus-host disease that requires immune-suppressing treatment (other than low-dose steroids as above)
• People who have another serious illness or medical condition that, in the doctor's opinion, could put them at risk or affect the study
• People who have a known allergy to any ingredient in the study treatment or to other medications used as part of the study
• Women who are currently breastfeeding
• People whose personal, psychological, social, or geographical circumstances mean that, in the trial doctor's opinion, participation would not be in their best interest or would make it difficult to follow the study requirements

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