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:

• You are willing to sign a consent form and agree to follow the study requirements
• You are between 18 and 75 years old
• Your doctors expect you to live for at least 3 months
• You have been diagnosed with acute myeloid leukemia (AML) that has come back or stopped responding to treatment, confirmed by a lab test, and your leukemia cells test positive for a protein called CD33
• A bone marrow test shows that at least 5% of your bone marrow cells are leukemia blast cells (abnormal cells)
• You are well enough to carry out basic daily activities (confirm with trial site for exact fitness level required)
• Your white blood cell count in your blood is at a specific level before starting treatment (confirm with trial site)
• Any side effects from previous cancer treatments have mostly resolved before you start this trial
• Your liver, kidneys, and other organs are functioning well enough within the week before starting treatment
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants must use reliable contraception during the trial and for 6 months after it ends

Who may not be able to join:

• You have a specific type of leukemia called acute promyelocytic leukemia, or your leukemia developed from chronic myeloid leukemia
• You have received cancer treatments such as chemotherapy, immunotherapy, targeted therapy, major surgery, or radiation therapy within about 4 weeks before starting the trial
• You have a serious heart condition, such as a history of heart failure, heart attack, or unstable chest pain, or your heart is not pumping blood effectively enough
• You have certain abnormal heart rhythm readings on an ECG, including a prolonged QT interval, a specific type of electrical blockage in the heart (confirm with trial site)
• You have an active autoimmune or inflammatory disease (such as lupus, rheumatoid arthritis, or inflammatory bowel disease), with some exceptions such as well-controlled thyroid conditions or skin conditions not needing systemic treatment
• You have been diagnosed with another type of cancer within the past 5 years, with some exceptions such as certain fully treated skin cancers
• Your blood pressure is not well controlled (above 150/100 mmHg)
• You have a significant lung disease or a condition called interstitial lung disease
• The leukemia has spread to your brain or spinal cord
• You have had an allergic reaction to similar types of antibody-based medicines, or to any ingredient in the study drug (BL-M11D1)
• You have previously had an organ transplant or a bone marrow/stem cell transplant from another person
• You have HIV, active tuberculosis, or an active hepatitis B or hepatitis C infection
• You currently have a serious active infection such as severe pneumonia or blood infection requiring treatment
• You have a significant build-up of fluid around your lungs, abdomen, pelvis, or heart that is causing symptoms or needs to be regularly drained
• You have taken part in another clinical trial within 4 weeks before starting this trial
• You are pregnant or breastfeeding
• The trial doctors have other concerns about your participation (confirm with trial site)

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