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:

This trial has two groups (Cohort A and Cohort B). Please read the section that may apply.

Cohort A — Large B-cell lymphoma:

Who might be able to join this group:

• People aged 19 or older who are willing to give written consent to participate
• People who have been diagnosed with certain types of large B-cell lymphoma confirmed by tissue testing, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, or primary mediastinal large B-cell lymphoma
• People whose lymphoma has come back or stopped responding to treatment after at least two rounds of chemotherapy (including rituximab and an anthracycline drug), and who have either already tried a stem cell transplant using their own cells, or have been found to not be suitable for one, or have chosen not to have one
• People who have at least one measurable area of disease (at least 1.5cm in size)
• People who are in generally good physical condition, able to carry out normal daily activities with only minor limitations (ECOG performance score of 0 or 1)
• People whose liver and kidney are working well enough, based on recent blood test results
• People whose blood counts are at acceptable levels without having needed a blood transfusion in the two weeks before screening
• People who have adequate lung function, with only mild or no shortness of breath and blood oxygen levels above 91% while breathing normal air
• People whose heart is working well, with no fluid around the heart and a pumping function (ejection fraction) of 50% or more, confirmed by a heart scan
• People for whom a suitable sample of their own immune cells can be collected for treatment manufacturing
• People with a life expectancy of at least 12 weeks
• People who agree to use highly effective contraception for at least 12 months after receiving the treatment, and until the treatment cells are no longer detectable on two consecutive tests

Cohort B — B-cell leukemia:

Who might be able to join this group:

• People aged 19 or older who are willing to give written consent to participate
• People with B-cell acute lymphoblastic leukemia that has come back or stopped responding to treatment, meeting at least one of the following: did not respond to two or more cycles of initial chemotherapy; came back within 12 months of first achieving complete remission; did not respond to one cycle of chemotherapy after relapse; has relapsed or not responded after two or more treatment courses; or has relapsed or not responded at least 100 days after a donor stem cell transplant
• People with more than 5% abnormal blast cells found in a bone marrow test taken within 4 weeks before screening
• People whose abnormal cells have tested positive for the CD19 marker on recent bone marrow or blood testing (if prior anti-CD19 treatment has been given, at least 90% of cells must still show this marker)
• People who have a specific genetic change called Philadelphia chromosome positive, AND either cannot tolerate a type of targeted drug called a TKI due to side effects, or whose disease has not responded to two or more different TKIs
• People in generally good physical condition (ECOG performance score of 0 or 1)
• People with acceptable blood count levels (with some flexibility if low counts are judged by the treating doctor to be caused by the leukemia itself)
• People whose liver and kidneys are working well enough based on recent blood tests
• People with adequate lung function, with only mild or no shortness of breath and blood oxygen levels above 91% on normal air
• People whose heart is working well, with no fluid around the heart and a pumping function of 50% or more, confirmed by a heart scan
• People for whom a suitable sample of their own immune cells can be collected for treatment manufacturing
• People with a life expectancy of at least 12 weeks
• People who are willing to attend all required visits and tests throughout the study
• People who agree to use appropriate contraception for at least 12 months after receiving the treatment, and until the treatment cells are no longer detectable on two consecutive tests

Who may not be able to join (applies to both groups unless noted):

• People with a current or past cancer diagnosis, except for certain skin cancers, cervical or breast carcinoma in situ, or superficial bladder cancer treated successfully with no recurrence for at least 3 years, or another cancer that was fully removed and has been in complete remission for at least 5 years
• People who have had unstable chest pain or a heart attack within the past 12 months
• People who have had a blood clot, pulmonary embolism, or significant bleeding problems within the past 6 months
• People who have had low blood oxygen, significant fluid around the lungs, or significant abnormal heart rhythm results within the past 6 months
• People whose cancer has spread to the brain or spinal fluid, confirmed by MRI scan at screening (for Cohort B, this applies specifically to cancer that has spread into the brain tissue)
• People with active hepatitis B infection (though people with a specific type of past hepatitis B exposure may still be considered if they are taking preventive antiviral medication)
• People with active hepatitis C infection (though people who test negative for active virus may still be considered)
• People who are HIV positive
• People with an active neurological autoimmune or inflammatory condition (such as Guillain-Barré syndrome or motor neurone disease)
• People with uncontrolled fast or irregular heart rhythms within the past 3 months
• People whose disease is rapidly progressing, as determined by the treating doctor
• People who have had major surgery requiring general anaesthetic or a breathing machine within the past 4 weeks (or within 2 weeks for certain types of chest surgery)
• People with a serious active infection requiring antibiotic, antifungal, or antiviral treatment
• People who have used another experimental medicine or device within the past 4 weeks
• People who are pregnant or breastfeeding
• People with a known allergic reaction to the ingredients in the trial treatment
• People who have previously received certain treatments including: any prior anti-CD19 therapy (Cohort A), adoptive T-cell therapy, gene therapy, or a donor stem cell transplant (Cohort A); or certain recent treatments including donor lymphocyte infusion, graft-versus-host disease treatment, CNS radiation, or specific chemotherapy regimens (Cohort B)
• People in Cohort A who are on blood-thinning tablets
• People in Cohort A who are currently eligible for and willing to have their own stem cell transplant
• People in Cohort A who have received anti-cancer treatments, high-dose steroids, or immunosuppressive drugs too recently before the planned treatment dates (specific timeframes apply — confirm with trial site)
• People in Cohort B with advanced cancer involvement in the central nervous system with symptoms, or a history of neurological conditions such as epilepsy, stroke, dementia, or brain swelling
• People in Cohort B with Burkitt's lymphoma/leukemia or a specific type of chronic leukaemia in blast crisis
• People in Cohort B with primary immune deficiency or inherited bone marrow failure conditions (such as Fanconi anaemia)
• People in Cohort B who have previously had a severe (Grade 4) reaction to anti-CD19 treatment, including severe cytokine release syndrome or severe neurological toxicity

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