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 years or older, of any sex
• People who have been diagnosed with a type of blood cancer called AML (acute myeloid leukemia) and have already received at least two rounds of treatment for it
• People whose AML has come back after a period of remission, or whose AML did not respond to their most recent treatment (those who never responded must have completed at least two rounds of initial treatment)
• People whose AML showed no detectable disease after their last treatment but now shows signs of the disease returning through a specific genetic blood test (NGS testing for NPM1)
• People who carry a specific immune system marker called HLA-A*02:01
• People whose AML has a specific genetic change in a gene called NPM1 (specifically mutation type A, D, G, or H)
• People who have suitable veins for a blood collection procedure called apheresis, or who are willing to have a central line placed for this purpose
• People who are willing and able to give informed consent and follow all study requirements

Who may not be able to join:

• People with a very high number of leukemic blast cells in their blood (over 20,000 per microlitre), unless a medication called hydroxyurea can bring that count down to below this level
• People whose AML exists only outside the bone marrow (in other parts of the body, but not in the bone marrow itself)
• People who are considered suitable candidates for a stem cell transplant
• People whose condition makes them eligible to receive an already-approved targeted therapy treatment (confirm with trial site)
• People who have received another experimental treatment within a certain time period before the trial starts (specifically within five half-lives of the study drug)
• People who have had a stem cell transplant and either: had the transplant within the past three months; have significant graft-versus-host disease needing ongoing treatment; or have certain ongoing side effects from the transplant rated Grade 2 or higher
• People who have another type of cancer that currently requires treatment
• People with bacterial, viral, or fungal infections that are not under control at the time of joining
• People with an active Hepatitis B or Hepatitis C infection
• People who test positive for HIV-1 or HIV-2
• People who have cancer involvement in the brain or spinal fluid that has not responded to chemotherapy injected into the spinal fluid or radiation treatment
• People with moderate to severe heart failure (classified as NYHA Class 3 or 4), or a history of this, unless a recent heart scan (echocardiogram within the past 3 months) shows the heart is pumping adequately (at least 45% ejection fraction)
• People with significantly reduced kidney function, as measured by specific blood and calculation-based tests (confirm with trial site for exact thresholds)
• People with certain elevated levels of bilirubin in their blood, unless this is due to a harmless condition called Gilbert's Syndrome
• People with significantly elevated liver enzyme levels (AST or ALT) in their blood
• People who are pregnant or currently breastfeeding
• People with a low level of general health and physical functioning, as rated on a standard scale used in cancer research (ECOG performance status greater than 2)
• People who are currently taking ongoing immune-suppressing medications, such as cyclosporine or systemic steroids
• Women who could become pregnant, and men who could father a child, who are unwilling to use effective contraception or abstinence for 12 months
• People with any other condition that, in the treating doctor's judgement, could make participation unsafe or affect the reliability of study results

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