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 at the time of signing the consent form
• People who have signed and dated a consent form after being fully informed about the trial before any study activities begin
• People who are willing to follow the trial's instructions and requirements throughout the study
• People who have been diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (a specific type of blood cancer) in its early, stable phase, and who have been treated with the same targeted cancer medication for at least 24 months
• People whose cancer is detectable at a low, stable level in the blood — not gone completely, but not rising or falling significantly over the past 6 months (the three most recent measurements must all fall within a specific narrow range, confirm with trial site)
• People who are generally well enough to carry out daily activities with little to no limitation, as measured by a standard medical scale (ECOG score of 0 or 1)
• People whose treating doctor considers them likely to cooperate with treatment and follow-up visits
• Women who could potentially become pregnant must have a negative pregnancy blood test within 3 days before the first dose and a negative urine pregnancy test on the day of the first dose, and must use a highly effective form of contraception throughout the study and for at least 3 months after the last dose
• Men whose partners could potentially become pregnant must use condoms during intercourse throughout the study period, including men who have had a vasectomy

Who may not be able to join:

• People who are planned to have a bone marrow transplant from a donor, or who had one less than 5 years ago, or who had one more than 5 years ago but experienced complications where the donor's immune cells attacked their body
• People who have an uncontrolled or serious active infection
• People currently taking immune-suppressing medications on an ongoing basis, other than a low dose of steroids (equivalent to 10mg or less of prednisone per day used briefly)
• People who have taken another experimental drug or participated in another experimental therapy within the past 28 days or within 5 half-lives of that drug, whichever is longer
• People with an active autoimmune disease (where the immune system attacks the body) or a recent history of one, except for well-controlled diabetes or a stable thyroid condition
• People with poor liver function based on blood test results showing certain liver markers significantly above normal levels
• People who have had another active cancer within the past 5 years, except for certain early-stage skin cancers or cervical cell changes that have been adequately treated
• Women who are pregnant or breastfeeding
• People who have had a major surgical procedure within 28 days before the first study treatment, or who are expected to need major surgery during the study
• People with other medical, psychiatric, or physical conditions that could interfere with treatment, affect their ability to follow the study requirements, or put them at high risk of complications
• People with known HIV, Hepatitis B, or Hepatitis C infections
• People with a known allergy or sensitivity to the study drug (vididencel) or any of its ingredients
• People whom the treating doctor believes would benefit more from switching to a different targeted cancer medication

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