Early 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:

For people with B-cell acute lymphoblastic leukaemia (B-ALL):

• A confirmed diagnosis of a type of blood cancer called CD19-positive B-ALL, based on established medical guidelines
• The cancer has come back or has not responded to treatment, meeting at least one of these situations: standard chemotherapy did not achieve remission; remission was achieved but lasted less than 12 months; one or more follow-up treatments have not worked; or the cancer has relapsed two or more times
• A bone marrow test showing a certain level of abnormal cancer cells (above 5% by standard microscopy, and/or above 1% by a more detailed cell analysis)
• People who test negative for a specific genetic marker called the Philadelphia chromosome, OR people who test positive for it but cannot tolerate or have not responded to two targeted treatments called TKI therapies

For people with B-cell non-Hodgkin lymphoma (B-NHL):

• A confirmed diagnosis of one of several specific types of B-cell lymphoma, based on established medical classification guidelines
• The cancer has come back or has not responded to treatment, meeting at least one of these situations: no response or relapse after two or more lines of chemotherapy; the cancer was resistant to initial treatment; or relapse after a stem cell transplant using the patient's own cells
• At least one tumour that can be measured and assessed using standard imaging criteria

For all participants (both B-ALL and B-NHL):

• Liver and kidney function test results within acceptable ranges as defined by the trial
• A heart scan showing the heart is pumping effectively (at least 50% efficiency)
• No active lung infection, and blood oxygen levels of 92% or above when breathing normal indoor air
• A life expectancy of at least 3 months, as estimated by a doctor
• A general health and physical functioning score of 0 to 2 on a standard medical scale (meaning able to carry out everyday activities, with at most some limitation in physically demanding tasks)
• The patient, or their legal guardian, is willing to participate and has signed a consent form

Who may not be able to join:

• People with a history of serious brain or neurological conditions, including head trauma, loss of consciousness, epilepsy, stroke, or brain bleeding
• People with certain heart conditions, including a prolonged QT interval on a heart tracing or a history of serious irregular heartbeat
• People who are pregnant or breastfeeding
• People with a severe active infection (minor infections such as a simple urinary tract infection or bacterial throat infection may not apply — confirm with trial site)
• People with an active hepatitis B or hepatitis C infection
• People who have been taking steroid tablets or injections in the two weeks before screening (inhaled steroids may be an exception — confirm with trial site)
• People who have previously received any CAR-T cell therapy or other genetically modified T cell treatments
• People whose liver or kidney function results fall outside specific limits set by the trial
• People with HIV infection
• People with other serious uncontrolled medical conditions considered unsuitable for the trial
• People whose situation, in the treating doctor's judgement, could increase risk or affect the reliability of the trial results

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