Phase 2 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 who have agreed to take part, have signed a consent form, and are able to attend scheduled visits and follow study procedures.
• People who have been diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) — including certain related conditions — whose cancer has gone into remission after chemotherapy or immunotherapy, but who are not able to have, cannot find a matching donor for, or have chosen not to have a stem cell transplant.
• People aged between 14 and 80 years old (inclusive), of any sex.
• People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard medical scale (ECOG score of 0–2, meaning fully active to capable of limited self-care).
• People whose cancer cells have been confirmed to carry a specific marker called CD19, shown by a laboratory test on bone marrow or blood samples.
• People whose doctors expect them to live for more than three months from the time they sign the consent form.
• People whose liver, kidney, heart, and lung function meet specific minimum standards set by the trial (confirm with trial site for exact values).
• People who have suitable veins for cell collection and whose blood counts (red blood cells, white blood cells, and platelets) meet minimum levels set by the trial — though the trial doctor may assess suitability individually if these levels are not fully met.
• Women who could become pregnant must have a negative pregnancy test at the start of the trial; all participants who are able to have children must agree to use contraception throughout the study.

Who may not be able to join:

• People whose leukemia involves a mixture of cell types (mixed-lineage or biphenotypic leukemia).
• People who have previously received a type of treatment called CAR-T cell therapy before this trial's screening or preparation stage.
• People with bone marrow failure conditions linked to genetic disorders, such as Fanconi anemia, Kostmann syndrome, or Shwachman syndrome, among others.
• People with active hepatitis B virus detected in their blood, a positive hepatitis C antibody test, detectable Epstein-Barr virus or cytomegalovirus in their blood, or a positive HIV antibody test.
• People who have had another type of cancer in the past five years (exceptions may apply for certain cancers that have been successfully treated and are considered very low risk — the trial doctor would assess this individually).
• People with certain serious heart conditions, including severe heart failure, uncontrolled abnormal heart rhythms, high blood pressure that cannot be controlled with standard treatment, unstable chest pain, a heart attack or major heart procedure within the past six months, or significant heart valve disease.
• People with uncontrolled epilepsy, a history of stroke or brain bleeding, cerebellar disease, or other active disorders of the brain or nervous system.
• People who have a significant build-up of fluid around the heart or lungs at the time of screening.
• People who have had a blood clot in a deep vein or in the lungs within six months before screening.
• People with a known allergy or sensitivity to any ingredient in the study treatment.
• People who have received a live vaccine within six weeks before screening.
• People who have a severe, active infection that is not under control at the time of screening.
• People who have recently taken part in another clinical trial or received an experimental or investigational treatment within a specified time period before cell infusion (confirm exact timeframes with trial site).
• People whose physical or mental health makes it difficult to give informed consent or follow the study's requirements, or who are unwilling to do so.
• People whom the trial doctor considers unsuitable for any other reason.

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