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:

• Adults aged 18 or older (for the dose escalation part of the trial), or people aged 12 or older for whom no curative treatment options, including transplant, are available (for the backfill cohort part of the trial).
• People with a confirmed diagnosis of an advanced blood cancer, specifically one of the following: relapsed or treatment-resistant acute myeloid leukaemia (AML); high-risk or very high-risk myelodysplastic syndrome (MDS) that has not responded to 4–6 cycles of a specific type of chemotherapy called hypomethylating agents; or chronic myelomonocytic leukaemia (CMML) that has also not responded to 4–6 cycles of those same chemotherapy drugs.
• People whose white blood cell count is below 25,000 per microlitre at the time of joining (a treatment to reduce white blood cell counts beforehand may be permitted).
• People who have a specific genetic marker called HLA-A*02:01, confirmed through prior testing.
• People whose general physical functioning meets certain performance standards — assessed using age-appropriate scoring scales (confirm with trial site).
• People whose side effects from any previous treatments have mostly resolved before joining, with minor exceptions such as mild hair loss.
• People who have waited a sufficient amount of time since their last treatment before joining — the required waiting period varies depending on the type of treatment previously received (confirm with trial site for specific timeframes).
• People whose kidneys and liver are functioning at an adequate level, confirmed by blood tests within 10 days before starting treatment.
• People who are able and willing to use effective contraception from the time of joining until 120 days after their last dose of the study drug.
• People (or their healthcare proxy) who are able and willing to provide written consent and follow study instructions.

Who may not be able to join:

• People who have previously received a type of therapy targeting CTSG, or any similar T-cell engaging treatment.
• People whose leukaemia has returned only in locations outside the bone marrow (known as isolated extramedullary relapse).
• People with currently active cancer in the central nervous system (brain or spinal cord), unless a spinal fluid test has come back negative after completing appropriate treatment.
• People with a known HIV infection.
• People with an active hepatitis B infection (people with documented clearance after treatment may be considered).
• People with an active hepatitis C infection (people with documented clearance after treatment may be considered).
• People who are pregnant or breastfeeding; pregnancy tests are required during screening and within 72 hours before the first dose.
• People who have experienced certain serious heart conditions in the past 6 months, such as a heart attack, uncontrolled chest pain, severe heart failure, dangerous heart rhythm problems, stroke, or a mini-stroke; or people with a specific abnormal heart rhythm measurement (QTcF greater than 480 milliseconds).
• People with active graft-versus-host disease (a complication that can occur after a stem cell transplant) that requires systemic immune-suppressing medication.
• People who have had another cancer diagnosis within the past 2 years, with some exceptions for certain skin cancers or cancers in situ that were treated with curative intent and are currently showing no signs of disease.
• People with any other medical condition, ongoing therapy, or abnormal test result that the trial doctor believes could interfere with the study or would not be in the person's best interest.
• People currently receiving any other anti-leukaemia treatment alongside the study drug, with limited exceptions (confirm with trial site).
• People who have taken part in another interventional clinical trial and received an investigational drug within 14 days or 5 half-lives (whichever is shorter) before starting the study drug.
• People receiving any systemic treatment to prevent graft-versus-host disease (topical treatments are permitted).
• People with a known allergy or sensitivity to the study drug or its ingredients.

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