Phase 2 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:

• People who have been confirmed by laboratory testing to have one of three specific types of lymphoma (PMBCL, EBV+ DLBCL, or THRLBCL) at one of the participating hospitals.
• People for whom a tumour tissue sample is available — either one already stored from a previous procedure, or one that can be collected through a new biopsy before the study begins.
• People whose disease meets the requirements for a standard treatment called CAR T-cell therapy — for example, whose cancer has come back or stopped responding after at least two previous treatments, or who are not suitable for a stem cell transplant after one previous treatment (confirm with trial site for specific eligibility details).
• People who are generally well enough to carry out all normal daily activities, or who have only minor limitations (rated 0 or 1 on a standard medical fitness scale).
• People whose heart is pumping at 50% or more of its normal capacity, as measured by a heart scan.
• People whose blood cell counts are at or above certain minimum levels — unless low counts are caused by the lymphoma itself affecting the bone marrow or spleen (confirm with trial site).
• People whose liver and kidney are working at or above certain minimum levels on blood tests (confirm with trial site for specific values).
• People who have at least one area of lymphoma that is large enough to be measured on a specialised PET/CT scan (at least 1.5 cm, or at least 1 cm if the lymphoma is outside the lymph nodes).
• People aged 18 years or older.
• People who are willing and able to read and sign a consent form agreeing to take part.
• Women who could become pregnant, and men who are sexually active, who agree to use effective contraception from the time of signing the consent form until at least 6 months after the last dose of the study treatment.

Who may not be able to join:

• People who urgently need treatment to reduce the size of their cancer right away.
• People who are currently taking part in another clinical trial using an experimental treatment.
• People who have had another type of cancer in the past, unless it was successfully treated at least 2 years ago with no signs of it returning, or was a limited skin cancer, a very early-stage cancer that was fully treated, or a low-risk prostate cancer being monitored (confirm with trial site for exceptions).
• People who have received a live vaccine (such as measles, chickenpox, yellow fever, or nasal flu spray) within the 30 days before joining the study.
• People who have previously been treated with a type of immune therapy called a PD-1 or PD-L1 inhibitor and either responded for less than 6 months, or had a severe immune reaction (grade 3 or higher) to it.
• People who have previously been treated with CAR T-cell therapy.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test before starting treatment.
• People whose lymphoma has spread to the brain or spinal cord and is currently active. A past history of it spreading there is allowed if it has been treated.
• People who have recently had a serious infection requiring antibiotic drips into a vein that finished 7 days or fewer before the first dose, or who have any ongoing uncontrolled infection.
• People who have an active Hepatitis B or Hepatitis C infection.
• People who have a history of HIV infection.
• People who have had radiation therapy within the past 2 weeks (a shorter gap may be allowed for limited palliative radiation to areas outside the brain — confirm with trial site).
• People who have had other cancer treatments in the last 2 weeks, or experimental treatments in the last 4 weeks.
• People with significant liver disease such as active hepatitis or cirrhosis.
• People who have previously had a serious immune overreaction condition called macrophage activation syndrome (MAS) or haemophagocytic lymphohistiocytosis (HLH).
• People with uncontrolled heart rhythm problems, severe heart failure, or who have had a heart attack or serious heart event within the past 6 months.
• People with certain brain or nervous system conditions, including a stroke or bleeding in the brain within the past 3 months, or an active seizure disorder. Past lymphoma in the brain is allowed if it was successfully treated and there are no current signs of it.
• People who have had a transplant of a solid organ or someone else's stem cells at any time, or their own stem cells within the past 6 weeks.
• People who have an active autoimmune disease that has needed ongoing medication or treatment in the past 2 years.
• People who are taking steroid tablets at a dose higher than 10 mg of prednisone (or equivalent) per day, or any other medicines that suppress the immune system, within the 7 days before joining the study. Routine hormone replacement therapies are generally allowed (confirm with trial site).
• People with active lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease).
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.
• People with a condition, past history, or ongoing circumstance that the treating doctor believes could affect the safety of the study or the person's ability to participate fully.
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the study requirements.
• People who do not meet the standard medical requirements for CAR T-cell therapy.

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