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 to 70 years old, of any gender
• People who have a type of blood cancer called CD19-positive B-cell acute lymphoblastic leukaemia (B-ALL) that has come back after treatment or has not responded to treatment, confirmed by bone marrow testing showing at least 5% cancer cells, or by a sensitive test showing a measurable level of remaining cancer — and where other treatment options have been exhausted
• People whose leukaemia has relapsed for a second time or more in the bone marrow, or has come back after a bone marrow/stem cell transplant, or whose disease did not go into remission after two rounds of standard chemotherapy, or who stopped responding to chemotherapy after an initial remission
• People whose side effects from past treatments have settled down to a mild level (Grade 1 or lower), apart from blood-related side effects or minor issues like hair loss
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2)
• People whose kidneys, liver, lungs, and heart are working well enough to meet specific medical measurements (confirm details with trial site)
• People who are willing to use birth control from the time of joining the trial until 6 months after completing the preparatory chemotherapy; women who could become pregnant must have a negative pregnancy test beforehand (this does not apply to those who have had surgical sterilisation or have been through menopause for at least 2 years)
• People who are willing to take part voluntarily and sign a consent form

Who may not be able to join:

• People whose treating doctor estimates their life expectancy is less than 3 months
• People who have had another cancer diagnosed within the past 3 years, unless it was certain types of early-stage or fully treated cancers such as cervical cancer in situ, non-melanoma skin cancer, or certain early-stage bladder tumours
• People who have previously received a therapy that specifically targeted CD19
• People who have previously received CAR-T cell therapy or any other type of genetically modified T-cell therapy
• People who have active leukaemia that has spread to the fluid and lining around the brain and spinal cord (called CNS-3 disease)
• People whose B-ALL is suspected to have spread outside the bone marrow to other parts of the body
• People with a specific subtype of leukaemia called Burkitt cell leukaemia (L3 ALL) or mixed lineage acute leukaemia
• People with significant brain or nervous system conditions, such as a history of seizures, stroke, dementia, or certain autoimmune diseases affecting the brain
• People with a history of severe, permanent nerve damage caused by previous leukaemia treatment
• People who have had radiation therapy within the past 8 weeks (except radiation used to prevent cancer spreading to the brain)
• People who have received anti-leukaemia treatment within a certain recent time window before the trial treatment is given (confirm timeframe with trial site)
• People who have had a serious allergic reaction to the drugs used to prepare the body before treatment, or to any component of the trial therapy
• People with an uncontrolled infection currently requiring treatment through a drip (intravenous antibiotics or antifungals)
• People with uncontrolled or active infectious diseases including HIV, active hepatitis B or C, Epstein-Barr virus, or cytomegalovirus
• People whose cancer has spread into the heart chambers
• People who have had a heart attack, heart procedure (such as stenting or angioplasty), unstable chest pain, or another serious heart condition within the past 12 months
• People who may need urgent cancer treatment within 6 weeks due to a pressing medical emergency related to their cancer
• People with a condition where the immune system does not work from birth (primary immunodeficiency)
• People with a history of autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused organ damage or required ongoing immune-suppressing medication within the last 2 years
• People who have had a blood clot in the leg or lungs requiring blood-thinning medication within the past 6 months
• People with any other medical condition that could interfere with how the trial assesses safety or effectiveness
• People who have received any vaccine within 6 weeks before the planned start of the preparatory chemotherapy
• People who, in the investigator's judgement, are unlikely to complete all required trial visits and procedures

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