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 are 18 years of age or older.
• People who have been diagnosed with relapsed or refractory acute myeloid leukaemia (AML) — meaning the leukaemia has come back or has not responded to previous treatment.
• People whose leukaemia cells have tested positive for certain markers called CLL1 or CD33.
• People who are in reasonably good general health and able to carry out daily activities, with a life expectancy of more than 12 weeks (confirm with trial site).
• People whose kidneys are working well enough, based on blood test results meeting specific thresholds.
• People whose liver is working well enough, based on blood test results for bilirubin, ALT, and AST meeting specific thresholds.
• People whose blood clotting test results (INR and aPTT) fall within an acceptable range.
• Women who could become pregnant must have a negative pregnancy blood test before joining.
• People who test negative for donor-specific antibodies (a type of immune marker) at a level below a set threshold.
• People who are willing and able to sign a consent form agreeing to take part in the study.

Who may not be able to join:

• People who have a known allergy to any of the drugs or treatments used in this trial.
• People who have received certain cancer treatments too recently before the first treatment in this trial, including: steroids within 3 days; systemic anti-cancer therapy within 2 weeks; radiotherapy within 4 weeks; donor lymphocyte infusion within 6 weeks; treatment injected into the fluid around the spine within 1 week; or CAR-T, CAR-NK, or other gene-modified cell therapies within 6 months.
• People who have previously had an allogeneic stem cell transplant (a transplant using cells from another person).
• People who have received a vaccine within 4 weeks before the first treatment, or who are expected to need a vaccine during the study period or within 12 weeks after the last treatment.
• People who have leukaemia that has spread to the brain or spinal fluid (central nervous system leukaemia).
• People who have a specific subtype of leukaemia called Acute Promyelocytic Leukaemia (APL).
• People who have had another type of cancer in the past, unless they completed curative treatment more than 5 years ago and have had no signs of it returning.
• People with a history of brain or nervous system conditions such as epilepsy, stroke, paralysis, or problems with speech.
• People with active autoimmune diseases (conditions where the immune system attacks the body).
• People with serious heart or blood vessel conditions, including dangerous heart rhythm problems, a corrected QT interval over 480 ms, a recent heart attack, heart failure, aortic dissection, stroke, or other serious cardiovascular events within the past 6 months; significant heart failure based on standard heart function tests; or high blood pressure that cannot be controlled with medication.
• People with active lung infections, blood oxygen levels at or below 90%, or certain lung conditions such as pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease.
• People with uncontrolled bacterial, fungal, or viral infections, or known HIV infection, or active hepatitis B or hepatitis C infection.
• People with a history of substance abuse.
• People who still have significant side effects from previous cancer treatment that have not sufficiently recovered (confirm with trial site for specific grading thresholds).
• People who have had major surgery within 4 weeks before the first treatment (routine diagnostic biopsies are excluded from this).
• People who are pregnant or breastfeeding.
• People who, in the view of the trial doctor, have any medical or personal circumstances that could interfere with safe participation in the trial.

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