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
• People whose HLA tissue type (a biological marker) matches at two specific points called HLA B and C loci
• People diagnosed with a type of blood cancer called AML, where at least 20% of the cancer cells carry a protein called CD123 (at any point during their illness)
• For the first part of the trial (Phase 1a): people whose AML has not responded to all standard or life-extending treatments, or who cannot tolerate those treatments
• For the second part of the trial (Phase 1b): people whose AML has returned up to three times and has not responded to all standard or life-extending treatments, or who cannot tolerate them; who have up to 30% cancer cells (blasts) in a bone marrow test at screening, or between 30–40% blasts on two tests taken one to two months apart; and who do not have rapidly growing disease requiring urgent treatment to reduce cancer cell numbers
• People with a low level of remaining AML (called MRD-positive AML) may also be considered, provided specific conditions are met and the trial sponsor approves their inclusion (confirm with trial site)
• People who are generally well enough to carry out daily activities with little or no limitation (a health score of 0 or 1 on a standard scale used by doctors)
• People expected to live for at least 3 more months, in the treating doctor's judgement
• People with adequate kidney, liver, and heart function based on test results
• People who already have, or are willing to have, a long-term central venous access device (a type of tube inserted to allow easy access to a vein)
• People who are able to give written consent to take part
• People weighing at least 45 kg
• People who are not pregnant and who are using a highly effective form of contraception

Who may not be able to join:

• People with a specific subtype of leukaemia called acute promyelocytic leukaemia (APL, involving a chromosome change called t15;17)
• People whose AML exists only outside the bone marrow (for example, as a tumour called a chloroma or myeloid sarcoma)
• People whose AML has spread to the brain or spinal cord (central nervous system)
• People with bone marrow failure conditions
• People with significant heart problems, including severe heart failure, unstable coronary artery disease, a heart attack, or serious heart rhythm problems requiring medication in the past 6 months
• People with active lung disease causing noticeably low oxygen levels
• People with Parkinson's disease or epilepsy with symptoms in the past 12 months
• People who have had a stroke, seizure, or bleeding in the brain in the past 12 months
• People with a history of serious blood clotting conditions (such as DIC, deep vein thrombosis, or blood clots in the lungs) within the past 3 months
• People with an active infection that the doctor believes would be unsafe in this trial or would make a pre-treatment step called lymphodepletion unsafe
• People with a bladder condition called haemorrhagic cystitis (bleeding of the bladder lining)
• People who still have significant side effects (above a mild level) from previous cancer treatments
• People who had a stem cell transplant from a donor within the past 2 months, or who have graft-versus-host disease (a complication of transplant) requiring immune-suppressing medication
• People who received a live virus vaccine less than 2 weeks before the lymphodepletion step of the trial
• People who had major surgery within 28 days before the planned trial treatment infusion
• People who have had another cancer in the past 3 years, or any cancer that currently requires active treatment (some exceptions may apply with sponsor approval — confirm with trial site)
• People who received another experimental drug or therapy within 4 weeks (or 5 half-lives, whichever is shorter) before the lymphodepletion step
• People who received anti-leukaemia treatment within 4 weeks (or 5 half-lives, whichever is shorter) before the lymphodepletion step
• People who have previously received gene-modified cell therapy of any kind
• People who have recently used checkpoint inhibitor drugs (a type of cancer immunotherapy) within 5 half-lives of that drug
• People with autoimmune diseases requiring ongoing steroid or immune-suppressing treatment
• People who are pregnant or breastfeeding
• People with psychological disorders that required treatment changes in the past 3 months, or with significant active alcohol or drug misuse (in the doctor's judgement)
• People with a history of HIV or HTLV infection, or active or chronic hepatitis B or C infection
• People with certain autoantibodies associated with autoimmune conditions (specifically anti-La/SS-B antibodies), or a history of autoimmune diseases linked to those antibodies
• People with a known allergy or sensitivity to any of the trial's treatment components or to medications used in the preparation or support of the treatment
• People who, in the doctor's judgement, are unlikely or unable to follow the trial's requirements
• People who, in the doctor's judgement, are unable to understand the consent process or what participation involves

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