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 been diagnosed with multiple myeloma (a type of blood cancer) that can be measured through standard testing.
• People whose treating doctor has determined them to be eligible for a specific approved CAR-T cell therapy called ciltacabtagene autoleucel (a treatment where a patient's own immune cells are modified to fight cancer).
• People enrolling in the dose escalation stage of the trial who have already been treated with at least two previous lines of treatment and have been exposed to at least five different anti-myeloma drugs (not counting steroids or melphalan), including at minimum one drug from each of these categories: a proteasome inhibitor, an immunomodulatory drug, and a CD38 monoclonal antibody.
• People whose doctor estimates they have a life expectancy of at least 12 weeks at the time of enrolment.
• People aged 18 years or older.
• People with a general health and activity level rated at 2 or below on a standard medical scale (meaning they are able to care for themselves, though they may not be able to do heavy physical work) (confirm with trial site).
• People whose liver and kidney function meet specific minimum levels as determined by blood tests (confirm with trial site).
• People who are willing and able to use reliable contraception from before the study starts until 90 days after finishing the study treatment (around Day 125 after CAR-T therapy), and who agree to immediately inform their treating doctor if a pregnancy occurs or is suspected during this time.
• People who are able to understand and are willing to sign a written consent form approved by an ethics review board; a legally authorised representative may sign on a participant's behalf if needed.

Who may not be able to join:

• People who have previously received any treatment that directly targets a protein called BCMA on cancer cells.
• People who have or have had another type of cancer whose history could interfere with assessing the safety or effectiveness of this trial's treatment.
• People who have received another experimental treatment within 14 days before their CAR-T cell infusion, or who are currently receiving one.
• People with a history of serious allergic reactions to substances with a similar chemical or biological makeup to the study drug NT-I7 or other agents used in this trial.
• People with serious uncontrolled illnesses, including active infections (bacterial, fungal, viral, or tuberculosis), known hepatitis A, B, or C, HIV, uncontrolled heart failure, unstable chest pain, or certain heart rhythm problems; people with significant heart disease history must meet a minimum heart function rating on a standard scale (confirm with trial site).
• People who are pregnant or breastfeeding, or people of childbearing potential who do not have a negative pregnancy blood test within 14 days before starting CAR-T therapy.
• People who have received a live or weakened-virus vaccine within 30 days before the first day of treatment.
• People who have had an organ transplant or a stem cell transplant using cells from another person.
• People who are unable to receive injections into the muscle.
• People with a prior history of a cancer affecting T cells (a type of immune cell).
• People with a prior history of a congenital (present from birth) immune system deficiency condition.
• People with a history of an autoimmune disease that has been significantly active within the past two years, including conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, certain skin conditions affecting immune cells, blood vessel inflammation, kidney inflammation, Bell's palsy, Guillain-Barré syndrome, or multiple sclerosis.
• People with a prior history of plasma cell leukaemia, a condition called systemic amyloidosis, POEMS syndrome, or multiple myeloma that has spread to the brain or spinal cord.
• People who are planning to start maintenance therapy before Day 100 following their CAR-T therapy.
• People with a history of significant lung conditions, such as severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, a serious blood clot in the lungs within the past 3 months, or active or previous inflammation of the lung tissue.

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