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:

• Adults aged 18 or older at the time of signing the consent form
• People who are able to give written consent to participate in the study
• People who have been diagnosed with a specific type of chronic myelomonocytic leukemia (CMML) that tests positive for a protein called CD4, and whose disease has come back or has not responded to standard first-line treatment
• People whose kidneys are functioning well enough, as measured by a specific blood test (confirm with trial site)
• People whose liver enzyme levels (ALT/AST) are within an acceptable range, less than 3 times the upper limit of normal
• People whose bilirubin levels (a measure of liver function) are less than 2 times the upper limit of normal
• People who do not need extra oxygen while at rest
• People whose heart is pumping adequately, with a heart function measurement (ejection fraction) of at least 50%
• People who have suitable veins for the blood collection process (leukapheresis) required by the trial

Who may not be able to join:

• People whose CMML tests negative for the CD4 protein
• People who are pregnant or currently breastfeeding (a negative pregnancy test is required before the chemotherapy preparation stage, for those who could become pregnant)
• People who have an active, uncontrolled infection that is currently being treated with systemic medications
• People with an active hepatitis B or hepatitis C infection — though people with a past history of hepatitis B or C who completed antiviral treatment and have shown no detectable virus for at least 6 months may still be considered eligible (confirm with trial site)
• People who are currently taking high-dose steroid medications (above standard replacement levels) or who are dependent on steroids in a way that cannot be safely reduced before joining the trial — note that low-dose replacement steroids and inhaled steroids are generally not disqualifying (confirm with trial site)
• People with any uncontrolled medical condition that, in the opinion of the treating doctor, would make participation unsafe
• People living with HIV
• People who have received or are due to receive a live vaccine within 30 days before the first treatment — standard inactivated flu vaccines are generally permitted
• People with active autoimmune diseases that have required systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) in the past year — though certain replacement therapies, inhaled steroids, vitiligo, and long-term remission of childhood asthma or allergies may not be disqualifying (confirm with trial site)
• People with a history of mental health disorders or substance misuse that may affect their ability to follow the treatment plan
• People who have had another active cancer (unrelated to CMML) that required treatment in the last 3 years, or that is not in full remission — some exceptions may apply, such as certain treated skin cancers or prostate cancer not requiring treatment (confirm with trial site)
• People who have received any experimental cell or gene therapy in the past 6 months
• People who have received any experimental cancer treatment within the last 14 days before joining the study, or within 5 half-lives of that treatment, whichever is shorter
• People whose CMML progressed to acute myeloid leukemia (AML) and whose treatment was unable to bring the disease back to CMML status
• People who, at the time of the actual cell infusion, require extra oxygen to maintain adequate blood oxygen levels, are showing worsening chest imaging results, have a new uncontrolled heart rhythm problem, have dangerously low blood pressure requiring medication support, or have a confirmed blood infection within 48 hours of the planned infusion

Regarding pregnancy and contraception:

• All participants must agree not to attempt conception (including sperm donation or IVF) while enrolled in the trial, and must use two reliable forms of contraception from the time of consent until at least 90 days after the cell infusion, if there is any possibility of pregnancy resulting from sexual activity — acceptable methods include combinations of condoms, diaphragms, IUDs, and hormonal contraception (confirm specific requirements with trial site)

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