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 16 to 70 years old (inclusive).
• People who have been diagnosed with B-cell acute lymphoblastic leukaemia (B-ALL) that has come back after treatment or has not responded to treatment, and whose cancer cells carry a protein called CD19.
• People with leukaemia in the bone marrow must have lab results confirming at least 5% leukaemic cells present in the bone marrow.
• Side effects from previous cancer treatments must have mostly resolved, with only mild or no ongoing effects remaining (with some exceptions for blood-related side effects and minor issues like hair loss).
• People who are well enough to carry out daily activities, with a general health score indicating they are reasonably functional (confirm with trial site for exact definition).
• People whose kidneys are working well enough, based on blood test results.
• People whose liver is working well enough, based on blood test results.
• People whose heart is pumping effectively (at least 50% efficiency), with no fluid around the heart and no significant heart rhythm problems on testing.
• People whose blood clotting levels fall within an acceptable range on lab tests.
• People whose blood oxygen level is above 91% while breathing normal room air.
• People of any gender who are willing to use reliable contraception from the time of signing consent until 6 months after finishing the preparatory chemotherapy; women who could become pregnant must have a negative pregnancy test before joining (women who have had surgical sterilisation or have been through menopause for at least 2 years are not required to meet this condition).
• People who are willing to take part voluntarily and sign a consent form.

Who may not be able to join:

• People whose doctor estimates their life expectancy to be less than 3 months.
• People with a history of another cancer (other than certain minor skin cancers or very early-stage cancers) unless they have been cancer-free for at least 3 years.
• People who received immune cell therapy or a stem cell transplant within 3 months before joining the trial.
• People whose leukaemia is currently active in the fluid and lining around the brain and spinal cord (a specific stage called CNS-3).
• People with a significant, currently active problem affecting how the brain or nervous system is functioning.
• People with a known history of severe, permanent nerve or brain damage caused by previous leukaemia treatments.
• People who received anti-leukaemia treatment within a specific recent timeframe before receiving the trial treatment (confirm with trial site for exact timing details).
• People who had radiation therapy within 8 weeks before joining (except radiation used to prevent leukaemia spreading to the brain and spinal cord).
• People with a known history of a severe allergic reaction to any substance used in this trial.
• People who have an active infection (fungal, bacterial, viral, or other) that is not under control or that requires IV antibiotics or antifungals.
• People with uncontrolled or active infections including HIV, active hepatitis B or C, or certain viral infections such as EBV or CMV.
• People with a history or current diagnosis of certain brain or nervous system conditions, such as seizures, stroke, dementia, or autoimmune diseases affecting the brain.
• People whose leukaemia has spread into the chambers of the heart.
• People who have had a significant heart event such as a heart attack, heart procedure, or unstable chest pain within the past 12 months.
• People who may need urgent cancer treatment within 6 weeks due to a rapidly developing complication of their cancer.
• People with a primary immune deficiency condition.
• People with a history of an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has damaged organs or required ongoing immune-suppressing medication within the last 2 years.
• People who have had a blood clot in a vein or lung requiring blood-thinning medication within the past 6 months.
• People with any other medical condition that could interfere with the trial's ability to assess whether the treatment is safe or effective.
• People who received a vaccine within 6 weeks before the planned start of the preparatory chemotherapy.
• People whose immune system has produced specific antibodies that would react against the trial's CAR-T cell therapy (confirm with trial site for exact testing details).
• People who, in the investigator's opinion, are unlikely to be able to complete all required trial visits, procedures, or follow-up requirements.

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