Early 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 19 to 75 years old, of any gender, who (or whose guardian) are willing to sign a consent form agreeing to take part.
• People diagnosed with a plasma cell disease — such as Multiple Myeloma, Plasma Cell Leukemia, or AL Amyloidosis — that has come back or stopped responding to treatment, and who have already tried at least 3 previous treatments (including treatments from the proteasome inhibitor and immunomodulatory drug groups).
• People whose disease was shown to be getting worse during or within 12 months of their most recent treatment (if the last treatment was a CAR-T cell therapy, this 12-month time limit does not apply).
• People whose cancer cells have been shown to carry a protein called BCMA on their surface, confirmed by a laboratory test on tumour tissue.
• People who are unable to have a stem cell transplant using their own cells, or whose disease has returned after having one, and whose doctor has determined that further treatment is needed.
• People with a general health/activity score of 0–2 on the ECOG scale, meaning they are able to carry out most daily activities (confirm with trial site for cases involving the central nervous system).
• People with an estimated life expectancy of at least 12 weeks.
• People whose blood counts, liver, kidney, electrolyte, clotting, and heart function all meet the specific minimum levels required by the trial (detailed blood and organ tests will be done to check this).
• People willing to provide records from their original diagnosis and to undergo bone marrow examinations before and during the trial.
• People (women of childbearing potential and all men) willing to use effective contraception for at least 12 months after receiving the treatment, and until two consecutive tests show no remaining CAR-T cells in the body.
• People whose disease is measurable by at least one of the following: a certain level of abnormal plasma cells in the bone marrow; detectable abnormal protein (M-protein) in the blood or urine above specified levels; or measurable tumour deposits outside the bone marrow.

Who may not be able to join:

• People who have had a stem cell transplant within 2 months before the planned treatment infusion, or who are still taking medication to suppress the immune system following a transplant.
• People who have had major surgery within 4 weeks before the screening period.
• People who have had radiotherapy within 2 weeks before the screening period.
• People who have received a treatment injected into the fluid around the spine within 1 week before the planned infusion.
• People who have received a live vaccine within 4 weeks before the planned infusion, or who plan to receive one during the trial.
• People who have received treatment as part of another clinical trial within 4 weeks before the planned infusion, or who are currently enrolled in another clinical trial.
• People with a moderate or severe heart rhythm problem, or specific abnormal heart electrical readings, or a history of certain serious heart rhythm conditions.
• People who have had a serious heart or blood vessel event in the 12 months before screening — such as a heart attack, unstable chest pain, heart failure, heart bypass surgery, or a stroke or mini-stroke.
• People with an active, uncontrolled infection at the time of screening, as assessed by the study doctor.
• People who are HIV positive.
• People with active Hepatitis B infection (based on specific blood test results).
• People with active Hepatitis C infection (based on specific blood test results).
• People with serious electrolyte imbalances in their blood, as assessed by the study doctor.
• People with signs of active or significant gastrointestinal bleeding, including active stomach ulcers, blood in the stool above a certain level, or a history of vomiting blood or black stools within 2 months before screening.
• People who have previously had a solid organ transplant (such as a kidney or liver transplant).
• People with other serious medical or psychological conditions that the study doctor considers would make participation unsafe or unsuitable.
• Women who are pregnant or breastfeeding.
• People currently receiving other cancer treatments, including some traditional herbal medicines.
• People taking medications known to affect heart rhythm in a specific way (including certain heart rhythm drugs).
• People who require daily supplemental oxygen.
• People using long-term oral or systemic corticosteroids (steroid medications taken by mouth or injection, not inhaled).
• People with a history of substance misuse that cannot be stopped, or with a diagnosed mental health disorder.
• People with other conditions or health problems that the study doctor believes could put them at serious risk or prevent the trial from being completed properly.
• People from whom it is not possible to collect enough of the specific white blood cells needed to make the CAR-T cell treatment.

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