Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 an informed consent form agreeing to take part in the study
• People aged 18 or older
• People expected to live for at least 3 months
• People who have been diagnosed with a type of blood cancer called AML (acute myeloid leukemia) — either primary AML or AML that developed from a prior blood condition called myelodysplastic syndrome — where the cancer has come back or stopped responding to standard treatment, and where lab tests have confirmed the cancer cells carry a protein called CD33
• People whose general physical condition is reasonably good, as measured by a standard scale called the ECOG performance status (scores 0, 1, or 2, meaning able to carry out daily activities with little to no limitation)
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better, with some exceptions for hair loss and certain hormone-related conditions that are being managed
• People whose liver and kidney are functioning at an adequate level, as measured by specific blood and lab tests (confirm with trial site for exact values)
• People who agree to use highly effective birth control methods during the study and for 7 months after the last dose of treatment, along with an additional barrier method such as a condom
• Women who could become pregnant must have a negative blood pregnancy test at the start of the study and must not be breastfeeding

Who may not be able to join:

• People diagnosed with specific subtypes of blood cancer called acute promyelocytic leukemia (APL) or chronic myelogenous leukemia in blast crisis (CML)
• People who have received chemotherapy, immunotherapy, radiation therapy, major surgery, targeted therapy, or other cancer treatments within the 2 weeks before starting the study; or certain specific drugs (mitomycin or nitrosoureas) within 6 weeks before starting
• People who have a history of serious heart problems, such as significant heart failure, a heart attack, unstable heart rhythm, or chest pain due to heart disease, occurring within 6 months before screening
• People with certain abnormal heart electrical readings (such as a prolonged QT interval on an ECG), specific heart conduction problems, or certain risk factors for a dangerous heart rhythm condition called Torsades de Pointes — or who are currently taking medications known to affect heart rhythm in this way
• People with active autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, or psoriasis requiring whole-body (systemic) treatment — though some manageable conditions such as controlled hypothyroidism or Type 1 diabetes may be acceptable (confirm with trial site)
• People with another active cancer diagnosis, with some exceptions for certain fully treated skin cancers or other cancers treated with curative intent at least one year ago with no signs of return
• People with high blood pressure that is not well controlled, even with two or more blood pressure medications
• People who currently have an active complication from a prior bone marrow or stem cell transplant called graft-versus-host disease (GVHD), or who are taking more than a low dose of steroid medications to manage GVHD
• People currently receiving medications that suppress the immune system
• People with evidence of a serious blood clotting disorder called disseminated intravascular coagulation (DIC), though mild, stable cases may be considered after discussion with the trial sponsor
• People who have had a stroke or a brief stroke-like episode (TIA) within the 6 months before screening
• People who have had a blood clot in a vein or in the lungs within the 6 months before screening, unless they are in a stable condition and have been on appropriate blood-thinning treatment for at least 3 weeks
• People whose AML has spread to the brain or spinal fluid in an active, uncontrolled way (confirm with trial site regarding specific circumstances)
• People who already have moderate or severe nerve damage in their hands or feet (called peripheral neuropathy, Grade 2 or higher)
• People with serious lung conditions that are not well controlled, such as severe COPD, difficult-to-control asthma, restricted lung function, or high blood pressure in the lungs
• People who have a history of a non-infectious lung inflammation condition (called interstitial lung disease or pneumonitis) that needed steroid treatment, who currently have this condition, or where this condition cannot be ruled out on imaging at screening
• People who have had a severe allergic reaction to similar types of antibody-based medicines or to any ingredient in the study drug (BL-M11D1)
• People with HIV infection, unless specific conditions are met: the virus is undetectable in blood, immune cell counts are adequate, there have been no serious HIV-related infections in the past year, and the person has been on stable HIV medication for at least 4 weeks (confirm with trial site)
• People with active Hepatitis B infection, unless specific conditions are met around viral levels, liver test results, and antiviral treatment (confirm with trial site)
• People with active Hepatitis C infection, unless specific blood tests confirm the virus is no longer detectable
• People with active or latent tuberculosis
• People who have had a serious, uncontrolled infection requiring intravenous antibiotic, antiviral, or antifungal treatment within 1 week before starting the study
• People who have taken part in another clinical trial and received an experimental drug within 2 weeks before starting this study
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who have previously been treated with a specific type of cancer drug called a topoisomerase inhibitor-based antibody-drug conjugate (ADC)
• People with a history of serious bowel or stomach problems, including severe diarrhea, bowel inflammation, gastrointestinal bleeding, or major abdominal surgery
• People whose AML has progressed after more than 2 different types of systemic chemotherapy treatments, though those with 3 prior treatment lines or a prior stem cell transplant may be considered with approval from the trial sponsor (confirm with trial site)

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