Phase 1 Lymphoma 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:

• People who are able to understand the study and are willing to sign a written consent form (non-English speakers may be able to use an interpreter during early steps while a translated form is arranged)
• People who agree to allow the use of stored tissue samples from a previous tumor biopsy (exceptions may be possible with approval from the lead researcher)
• People aged 18 or older
• People whose general physical health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scale (ECOG score of 0–2)
• People with a confirmed diagnosis of primary central nervous system (CNS) lymphoma, where the disease can be measured on scans or detected in spinal fluid, or people with secondary CNS lymphoma that has returned only in the CNS (as confirmed by specific imaging, and at the lead researcher's discretion)
• People whose tumor currently tests positive for a protein called CD19, if they have previously received a treatment that targeted CD19
• People who have already tried and not responded to, or could not tolerate, standard CNS-directed chemotherapy treatments (such as high-dose methotrexate or high-dose cytarabine-based regimens)
• People who have previously received CAR T cell therapy, provided at least 3 months have passed before the cell collection procedure — and if prior CAR T cells also targeted CD19, the level of those cells remaining in the body must be below a certain threshold
• People who have no known medical reasons preventing them from undergoing the cell collection procedure (leukapheresis), steroid treatment, or a drug called tocilizumab
• People of reproductive potential who agree to use an accepted form of contraception throughout the study and for 3 months after the last treatment
• People whose liver function, kidney function, heart function, blood cell counts, oxygen levels, and infectious disease test results all fall within the required ranges (tested within a specified timeframe before enrolment)
• People who test negative for HIV, active Hepatitis B, Hepatitis C, and syphilis (or, where certain antibody results are positive, whose viral load tests come back undetectable)
• People who are women of childbearing potential and have a negative pregnancy test within 14 days of signing the consent form

Who may not be able to join:

• People who have not yet recovered from side effects of a previous treatment
• People who have lymphoma present outside the CNS (systemic lymphoma)
• People with a significant heart rhythm problem that has not been stable with medication in the two weeks before consent
• People with a known history of optic neuritis, seizure disorder, or other immune or inflammatory conditions affecting the brain or nervous system
• People with an active autoimmune disease that requires ongoing immune-suppressing treatment
• People who need more than a certain daily dose of the steroid dexamethasone (above 4mg/day or equivalent) within 72 hours before the cell collection or CAR T cell treatment
• People with a history of allergic reactions to similar treatments or other agents used in this study
• People with known bleeding disorders such as von Willebrand's disease or haemophilia
• People who have had a stroke or bleeding in the brain within the 6 months before signing the consent form
• People with a history of another cancer, unless it was treated with the intent to cure, has shown no signs of returning for at least 3 years, or was a limited type of skin cancer
• People with an uncontrolled active infection
• People with an active Hepatitis B or Hepatitis C infection, or whose Hepatitis B or C viral tests come back positive (confirm specific test requirements with the trial site)
• People with an HIV infection
• People with other significant active bacterial, fungal, or viral infections
• People with any other health condition that, in the treating doctor's judgement, would make participation unsafe
• People who, in the treating doctor's opinion, may not be able to follow all study requirements and procedures

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