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:

• People aged 18 to 70 years, of any gender
• People whose doctors estimate they are likely to live for more than 12 weeks
• People with a general health status that falls within a certain range, meaning they are able to carry out at least some daily activities (confirm with trial site regarding the specific fitness level required)
• People diagnosed with acute myeloid leukemia (AML) according to 2022 WHO guidelines, where a specific protein called CLL1 is found on a high proportion of the leukemia cells, AND whose disease has either come back after treatment (relapsed) or has not responded to treatment (refractory) — specific criteria apply depending on the treatment history and timing of relapse (confirm details with trial site)
• People whose veins are suitable for a blood collection procedure called leukapheresis, with no medical reasons preventing this
• People whose kidney function, liver function, heart function, and lung oxygen levels meet specific minimum thresholds set by the trial (confirm exact values with trial site)
• People who are able to understand the trial information and sign a consent form

Who may not be able to join:

• People whose AML involves a specific genetic change called PML-RARA fusion gene
• People who have had another type of cancer within the past 5 years, unless it was certain very early-stage or fully treated cancers such as cervical carcinoma in situ, basal cell or squamous cell skin cancer, or prostate or thyroid cancer treated with surgery
• People with active bacterial, viral, or fungal infections that are not under control; or people who test positive for hepatitis B, hepatitis C, syphilis, or HIV under the specific testing conditions outlined by the trial
• People with serious heart or lung problems; active internal bleeding in the digestive system in the past 3 months; uncontrolled high blood pressure or a history of hypertensive crisis; serious heart conditions such as heart failure, unstable chest pain, or dangerous heart rhythm problems; a stroke or similar event in the past 3 months; serious blood clot conditions in the past 6 months; or any other significant medical condition that could affect safety or the conduct of the trial
• People with any other active, uncontrolled illness that would prevent participation
• People with active, uncontrolled involvement of the central nervous system (brain or spinal cord) by leukemia, or a history of certain brain or nervous system conditions such as epilepsy that required treatment
• People currently taking steroid medications by mouth or injection (not inhaled or applied to the skin) who are expected to need to continue long-term, or people who have received such steroids within 72 hours before the planned cell treatment
• People who have received certain immunotherapy drugs known as PD-1 or PD-L1 inhibitors within the 3 months before joining the trial
• People who are pregnant or breastfeeding, or who plan to become pregnant within 1 year after receiving the cell treatment
• People with uncontrolled active infections, other than simple urinary tract or upper respiratory infections
• People who have previously received CAR-T therapy or any other gene-modified cell therapy
• People who have had an organ transplant from a donor (allogeneic transplant) and still have significant graft-versus-host disease (GVHD), or who have not yet stopped immunosuppressive medications for at least 1 month (confirm with trial site, as specific transplant-related rules apply)
• People with a known allergy to any component of the trial's cell therapy or to the chemotherapy drugs used (cyclophosphamide and fludarabine)
• People whose situation is judged by the trial doctors to make participation unsafe or unsuitable for any reason
• People who are unable to sign a consent form in writing or who are unwilling or unable to follow the trial's requirements

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