Phase 1 Leukaemia 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 read, understood, and signed a consent form and are willing to follow the study procedures
• Adults aged 18 or older at the time of signing consent
• People who have been diagnosed with acute myeloid leukemia (AML) that has come back or stopped responding to treatment, according to the 2016 World Health Organization classification
• People with a performance status score of 0–2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose doctors estimate they have a life expectancy of at least 3 months
• People whose blood, bone marrow, liver, kidney, and heart function meet specific levels set by the trial (the trial team will check these through tests)
• People who are able and willing to use medically approved contraception during the treatment period and for 6 months after the last dose, if there is any possibility of pregnancy for themselves or their partner

Who may not be able to join:

• People with a known allergy to WBC100 capsules or any of their ingredients
• People diagnosed with acute promyelocytic leukemia (APL), a specific subtype of leukemia
• People diagnosed with mixed phenotype acute leukemia, chronic myeloid leukemia in blast crisis, or AML that developed from certain pre-existing blood conditions (MDS or MPN)
• People who have relapsed after a donor stem cell transplant, have moderate-to-severe graft-versus-host disease, require ongoing immune-suppressing treatment for graft-versus-host disease, or have had their own stem cells transplanted within the past 90 days
• People who have had major surgery, have an active ulcer, or have a wound that has not healed within the 28 days before starting the trial
• People who have taken another experimental drug or been in another clinical trial within the 28 days before starting, or who are still in the follow-up phase of another trial
• People with a history of serious heart or blood vessel conditions, including significant irregular heartbeats, blood clots requiring blood thinners, severe heart failure (NYHA Class III–IV), or high blood pressure that is not well controlled despite treatment
• People with severe or poorly controlled health conditions such as difficult-to-treat fluid build-up, poorly controlled diabetes, or serious problems with mental health, nervous system, heart, lungs, hormones, digestive system, liver, or kidneys
• People with a history of immune system deficiency, autoimmune disease requiring ongoing immune-suppressing medication, or who have received an organ transplant
• People who have had congestive heart failure, a tear in the aorta, a stroke (other than very small ones), unstable chest pain, a heart attack, heart bypass surgery, or a blood clot in the lungs within the 180 days before starting the trial
• People with known risk factors for a specific heart rhythm problem called QT prolongation, including an inherited condition or a past history of drug-related heart rhythm problems
• People who test positive for syphilis, HIV, active hepatitis B, or active hepatitis C
• People with an active infection — such as a bacterial, viral, or fungal infection — that requires treatment
• People with digestive system conditions that would prevent them from taking or absorbing capsules by mouth, such as severe vomiting, ongoing diarrhea, a stoma, poor nutrient absorption, or inability to swallow
• People who are taking certain strong medications that significantly affect how the body processes drugs, if those medications cannot be stopped at least 7 days before the trial starts
• People who have recently received certain cancer treatments, including monoclonal antibodies, antibody-drug treatments, radiotherapy, chemotherapy, targeted therapy, or CAR-T cell therapy, within specific time windows before starting (the trial team will check these timeframes)
• People who have received a live or weakened live vaccine (such as influenza or chickenpox vaccines) within the 28 days before starting
• People with a history of another cancer within the past 2 years, except for certain treated skin cancers or early-stage cancers of the cervix or breast that have been fully treated
• People with a history of psychiatric or neurological conditions that may make it difficult to follow the trial requirements
• People who are unable to tolerate having blood drawn from a vein
• Women who are pregnant, breastfeeding, or who have a positive pregnancy test during the screening period
• Anyone the trial doctor considers unsuitable for the study for any other reason

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