Phase 2 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 aged 18 or older at the time of signing the consent form
• People who are willing and able to give written informed consent to take part in the study
• People whose general health and ability to carry out daily activities meets a specific functional standard (rated 0 or 1 on a scale used by oncology teams — confirm with trial site)
• People diagnosed with AML (acute myeloid leukaemia) or T-ALL (a type of blood cancer) where at least 5% of cells in the bone marrow or blood are abnormal (blast) cells, with no currently approved treatment options remaining, and who fall into one of these situations:
  • The disease did not respond to more than two rounds of initial chemotherapy
  • The disease has relapsed a second time or more
  • The disease came back and did not respond to at least one round of further treatment after relapse
  • The disease relapsed or did not respond after a stem cell transplant from a donor, provided the study treatment is given at least 3 months after that transplant
• People whose leukaemia cells have been confirmed to carry a specific protein called CD84, as shown by a lab test at screening
• People with T-ALL where the cancer cells have a specific pattern (called double-negative, meaning they lack both CD4 and CD8 markers), OR people with T-ALL that has CD4 and/or CD8 markers but where no abnormal blast cells are detectable in the blood
• People for whom a suitable stem cell donor is available (either a related or unrelated donor) within a set timeframe after treatment (30–90 days after receiving the study treatment)
• Women who could become pregnant must have a negative pregnancy test at screening and before receiving the study treatment
• Women who have not gone through menopause (defined as fewer than 24 months without a period) or who have not had surgery to prevent pregnancy must agree to use two forms of contraception — one highly effective method and one barrier method — during treatment and for at least 12 months after the last dose
• Male participants must agree to use two acceptable forms of contraception during treatment and for at least 12 months after the last dose
• People whose kidneys, liver, lungs, and heart are functioning well enough to meet specific health thresholds measured by blood tests, heart scans, and oxygen level checks (confirm specific values with trial site)

Who may not be able to join:

• People whose disease exists only outside the bone marrow (in other parts of the body only)
• Women who are pregnant or breastfeeding
• People with T-ALL that has CD4 and/or CD8 markers AND where abnormal blast cells can be detected in the blood
• People with a significant history of brain or neurological conditions such as epilepsy, stroke within the past 3 months, severe brain injury, dementia, Parkinson's disease, uncontrolled mental illness, or psychosis
• People with serious, uncontrolled heart conditions or a significant heart event within the past 12 months
• People with active, life-threatening bleeding
• People with an active serious infection (fungal, bacterial, viral, or other) that requires systemic medication to manage
• People who test positive for HIV, hepatitis B, or hepatitis C — though people who test positive for certain hepatitis markers may still be considered if a more specific blood test (PCR) taken within 6 weeks before treatment is negative (confirm with trial site)
• People with a history of autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that caused organ damage or required systemic treatment within the past 24 months, or any autoimmune disease affecting the brain or nervous system
• People with a history of another cancer, unless they have been free of that cancer for at least 12 months — certain exceptions may apply, such as some skin cancers or hormone-treated breast or prostate cancer (confirm with trial site)
• People with certain known inherited conditions affecting the bone marrow, such as Fanconi anaemia or similar syndromes
• People who had a stem cell transplant from a donor less than 3 months before receiving the study treatment
• People with active, significant graft-versus-host disease (a complication that can occur after transplant) requiring steroids or other immune-suppressing medications within 4 weeks of consenting
• People who have recently taken certain medications, including:
  • High-dose steroids within 7 days of the cell collection procedure or 72 hours before the study treatment
  • Immune-suppressing medications that have not been stopped at least 2 weeks before the cell collection procedure or study treatment
  • Donor immune cell infusions within the past 2 weeks
  • Medications for graft-versus-host disease that have not been stopped at least 2 weeks before the cell collection procedure
  • Certain antibodies that affect immune cells (such as alemtuzumab) within the past 6 months
  • Treatment injected into the fluid around the spine within 2 weeks before starting preparatory chemotherapy
• People who have taken part in another experimental clinical trial within 1 month before the study treatment
• People who are unable to tolerate the cell collection procedure (called leukapheresis)
• People who, in the view of the treating doctor, may not be able to follow the safety monitoring requirements or complete all required visits and procedures

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