Phase 3 Lymphoma 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:

Criteria that apply to everyone:

• People who are 18 years of age or older
• People whose participation in the cell collection process (leukapheresis) has been approved by the treatment team's specialist council
• People who are generally well enough to carry out basic daily activities (a standard health measure called ECOG must be below 2)
• People who have a life expectancy of at least 12 weeks
• People whose kidneys are filtering blood at an adequate rate (confirm with trial site for exact threshold and which pre-treatment medication applies to their situation)
• People whose liver function blood test results are within acceptable ranges, or where any abnormality is caused by their underlying cancer
• People whose heart is pumping blood effectively enough, confirmed by a heart scan
• People whose blood oxygen levels are above 92% while breathing normal room air without assistance
• People with an adequate level of infection-fighting white blood cells (this requirement may be waivable if low counts are caused by the cancer itself — confirm with trial site)
• People with an adequate platelet count (this requirement may also be waivable if low counts are caused by the cancer itself — confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test within 24 hours before pre-treatment begins, and also before the cell collection procedure
• People who are sexually active must use highly effective contraception for at least 12 months after receiving the CAR-T cell treatment
• People who have provided written consent to participate in the trial

Additional criteria for people with high-grade lymphoma:

• People with a confirmed diagnosis of one of the following: diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphoma, follicular lymphoma grade 3B, or high-grade B-cell lymphoma
• People whose cancer has not responded to chemotherapy, or who have relapsed within certain timeframes after previous treatment (confirm with trial site for exact definitions)
• People for whom a stem cell transplant using their own cells is not suitable, or who are unwilling to have one
• People who have previously been treated with specific types of chemotherapy, including an anti-CD20 antibody and an anthracycline-containing regimen; people with transformed lymphoma must have had at least 2 prior treatment courses
• People who have measurable disease that can be detected on scans, according to standard measurement guidelines

Additional criteria for people with other B-cell lymphomas (mantle cell, follicular, or marginal zone lymphoma):

• People with a confirmed diagnosis of mantle cell lymphoma, follicular lymphoma grade I to IIIA, or marginal zone lymphoma
• People with mantle cell lymphoma who have had up to 5 prior treatments including specific drug types; people with follicular or marginal zone lymphoma who have progressed after at least 2 combination treatment courses (confirm with trial site for exact definitions)
• People who have at least one tumour that can be measured on a scan, meeting minimum size requirements
• People with no known active lymphoma involvement in the brain or spinal fluid
• People whose side effects from previous treatments have mostly resolved (hair loss is an exception)
• People with a prior stem cell transplant using their own cells, early disease progression after treatment, or prior use of a specific class of targeted therapy (PI3K inhibitors) may still be considered eligible

Additional criteria for people with B-cell acute lymphoblastic leukaemia (B-ALL):

• People who meet at least one of the following: their leukaemia did not respond to initial treatment; they relapsed within 12 months; they have had at least 2 prior treatments; they relapsed after a donor stem cell transplant (at least 100 days after the transplant and off anti-rejection medication for at least 4 weeks); they have a specific type of leukaemia (Ph+) with limited or no remaining targeted therapy options; or they are not suitable for a donor stem cell transplant for documented medical or practical reasons
• People whose leukaemia is detectable in the bone marrow
• People with confirmed presence of the CD19 protein on their cancer cells, tested within the past 3 months
• People with a minimum level of lymphocyte cells in their blood
• People who have waited a sufficient period since their last immune checkpoint or immune-stimulating therapy (at least 3 half-lives of that therapy — confirm with trial site)

Who may not be able to join:

Criteria that apply to everyone:

• People with a serious, uncontrolled infection (for example, a positive blood culture within 72 hours before the treatment infusion)
• People who are HIV positive
• People with active hepatitis B virus replication or active hepatitis C infection
• People who have had unstable chest pain (angina) or a heart attack within the past 6 months
• People with an uncontrolled irregular heartbeat
• People who currently have another active cancer, unless it is a skin cancer that has been adequately treated, a cancer that has been in complete remission for at least 3 years, or a completely removed cancer with no signs of return for at least 3 years
• People who are pregnant or breastfeeding
• People with a known allergy to the ingredients used in the CAR-T cell product
• People with active autoimmune or inflammatory conditions affecting the nervous system
• People with a primary immune deficiency condition
• People who have recently received certain short-acting cancer treatments that have not been stopped far enough in advance
• People with a diagnosis of Burkitt lymphoma or Burkitt leukaemia
• People who are currently taking steroid medications above a very low threshold that have not been stopped at least 72 hours before treatment
• People the investigator considers unlikely to be able to follow the trial requirements

Additional exclusion criteria for people with high-grade lymphoma:

• People with active lymphoma involvement in the brain or spinal fluid
• People who have previously had a stem cell transplant using donor cells
• People still taking immune-suppressing medications that have not been stopped at least 1 week before the cell collection or infusion
• People who have not stopped anti-proliferative therapies at least 1 week before treatment
• People who have not stopped cytotoxic (cell-killing) drugs at least 1 week before treatment
• People who have not waited at least 4 weeks since receiving a donor lymphocyte infusion or certain antibody-based therapies (including anti-CD20 and similar treatments) before cell collection and infusion
• People who have not stopped CNS (brain and spinal cord) preventive treatments more than 1 week before treatment
• People who have not stopped radiation therapy at least 2 days before cell collection and at least 1 week before the infusion

Additional exclusion criteria for people with low-grade lymphoma:

• People who have received a live vaccine within 6 weeks before the pre-treatment conditioning begins
• People whose tumour is causing urgent symptoms that require immediate treatment

Additional exclusion criteria for people with B-ALL:

• People who currently have moderate to severe graft-versus-host disease (a complication from a previous donor transplant where donor cells attack the body), or who have required systemic treatment for this condition within the past 4 weeks

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