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 are 18 years of age or older.
• People who are willing and able to sign a consent form and follow the study's requirements, including screening tests and providing regular samples of bone marrow and blood.
• People who have a confirmed diagnosis of AML (acute myeloid leukaemia) or MDS (myelodysplastic syndrome) that has come back or stopped responding to treatment.
• People whose cancer has returned, gotten worse, or who could not tolerate standard available treatments, or who have chosen not to receive those treatments.
• People whose white blood cell count is below 20,000 per microlitre at the time of the first dose (a medication called hydroxyurea may be used to help manage this beforehand).
• People whose general physical functioning falls within an acceptable range on a standard medical scale (meaning they are able to carry out everyday activities, with at most limited self-care ability) (confirm with trial site).
• People whose side effects from previous treatments have mostly resolved, except for certain blood-related changes that may still be present.
• People whose kidney function, liver function, and bilirubin (a substance linked to liver health) levels meet specific thresholds based on blood tests (confirm with trial site).

Who may not be able to join:

• People diagnosed with a specific type of leukaemia called acute promyelocytic leukaemia (APL).
• People with active leukaemia that has spread to the brain or spinal cord.
• People whose leukaemia has returned only in areas outside the bone marrow, without bone marrow involvement.
• People who have previously received a transplanted organ from another person.
• People who received a stem cell transplant from a donor within the last six months, or who still show signs of a complication called graft-versus-host disease (GVHD), or who are still taking immune-suppressing medications within 2 months before starting the trial drug.
• People who received radiation therapy within the past 28 days, radiation to the brain and spine within the past 8 weeks, or who have ever had whole-body radiation.
• People who received certain immune-boosting cancer treatments (called checkpoint inhibitors) within the past 42 days.
• People who have previously had a type of cell therapy called CAR-T therapy or similar modified T cell treatments.
• People who received most anti-leukaemia treatments within 14 days or 5 half-lives (whichever is shorter) before starting the trial drug, with limited exceptions.
• People who received certain short-acting or long-acting blood cell growth factor medications within 7 to 14 days before the first dose.
• People taking high-dose steroid medications or other immune-suppressing drugs within 14 days before the first dose (low-dose steroids equivalent to less than 10 mg of prednisone daily may be acceptable; topical steroids and steroid eye drops are allowed).
• People who have previously been treated with a drug that specifically targets a protein called FLT3 using a bispecific molecule or a targeted antibody.
• People who are currently in, or recently took part in, another clinical trial and received an experimental drug within the past 14 days (or 5 half-lives, whichever is longer).
• People who have another active cancer that has required treatment in the past 12 months, or that is expected to need treatment during the study.
• People with an active autoimmune disease (a condition where the immune system attacks the body), or a history of one, or a condition that requires ongoing steroid or immune-suppressing treatment — with some exceptions such as vitiligo, certain thyroid conditions, and resolved childhood asthma (confirm with trial site).
• People with a serious uncontrolled medical condition that could prevent them from safely receiving the trial treatment.
• People with any other condition, medication, or test result that the study doctor believes could put them at risk or affect the study results.
• People with an active, uncontrolled infection within 7 days before the first dose (use of preventive antiviral, antibacterial, or antifungal medications for a controlled chronic infection is allowed).
• People who have tested positive for HIV or have a known primary immune deficiency disease.
• People with a known history of hepatitis B, hepatitis C, or active hepatitis A, based on specific blood test results — though people with hepatitis C that has been successfully treated (with no detectable virus for at least 24 weeks after treatment) or hepatitis B with no detectable virus may still be eligible (confirm with trial site).
• People with an active COVID-19 infection, a recent positive COVID-19 test without a confirmed negative result afterwards, a test result still pending, or suspected active COVID-19 based on symptoms.
• People who experienced serious side effects (grade 3 or higher) affecting the nervous system, eyes, lungs, heart, or bowel as a result of previous immunotherapy treatment, or who had severe liver-related side effects from such treatment.
• People who have received a live virus vaccine within 28 days before the first dose, or who plan to receive one during or shortly after the trial.
• Women who are pregnant or breastfeeding, plan to become pregnant within 120 days after the last dose, or are unwilling to use an accepted method of contraception during the trial and for 120 days after the last dose.
• Men who plan to father a child or donate sperm within 120 days after the last dose, or who have a female partner who could become pregnant and are unwilling to use an accepted method of contraception during the trial and for 120 days after the last dose.
• People with a specific heart rhythm measurement (QTcF interval) of 480 milliseconds or more on an ECG (heart tracing).
• People who have had a severe allergic reaction to any component of the trial drug, or a grade 4 (life-threatening) allergic reaction to any similar type of drug (bispecific molecule or monoclonal antibody).
• People with a known history of developing antibodies against human-derived proteins used in similar treatments (confirm with trial site).
• People with known active alcohol or drug misuse.
• People who are unable to make their own decisions or who are involuntarily detained.

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