Phase 1 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:

• Adults aged 18 or older at the time of signing the consent form.
• People diagnosed with a specific type of lymphoma affecting the brain or central nervous system (called DLBCL subtype), confirmed through a tissue sample.
• People whose central nervous system lymphoma has come back after treatment (relapsed) or did not respond to treatment (refractory), and who have previously received at least one treatment directed at the central nervous system that included a drug called methotrexate.
• For people whose lymphoma has come back: brain imaging (MRI or CT scan) taken within 21 days of signing consent must clearly show the disease has progressed.
• For people whose lymphoma did not respond to treatment: there must be disease still present after the most recent treatment.
• For people with lymphoma affecting only the fluid around the brain and spine: lab tests on spinal fluid and/or imaging taken within 21 days of signing up must confirm lymphoma involvement in that area.
• People whose kidneys, liver, and related organ function meet specific minimum levels as measured by blood tests (confirm with trial site for exact values).
• People whose blood oxygen level is at least 90% while breathing normal room air.
• People who are able to undergo both MRI and CT scans.
• People who are able to undergo lumbar punctures (spinal taps) and/or a similar procedure called an Ommaya tap.
• People who have either stopped taking corticosteroid medications, or have been on a stable or reducing low dose for at least 7 days before the cell collection procedure and 72 hours before the treatment infusion.

Who may not be able to join:

• People whose overall health and ability to carry out daily activities falls below a certain level on a standard medical scale (ECOG score above 2; those with a score of exactly 2 may be considered at the treating doctor's discretion).
• People who have active lymphoma outside of the brain or central nervous system.
• People whose most recent spinal fluid or brain tissue sample shows the lymphoma cells do not carry a protein called CD19.
• People who have a single lymphoma lesion in a critical area of the brain that measures more than 3 cm across at its widest point.
• People who have previously been treated for systemic lymphoma with a CD19-targeted CAR T cell therapy.
• People who are pregnant or breastfeeding. People who could become pregnant are required to use effective contraception throughout the study and for one year after all treatment ends.
• People with reduced heart pumping function, specifically a heart pump measurement (LVEF) below 40% on a recent heart scan taken within the past year.
• People with an autoimmune disease that requires ongoing medication that suppresses the immune system's T cells.
• People with certain serious heart conditions, including severe heart failure (NYHA stage III or IV), a heart attack within the past 6 months, or a significant history of irregular heart rhythms or unexplained fainting within the past 6 months.
• People who have lymphoma affecting only the eyes, with no other central nervous system involvement.
• People who have received chemotherapy, targeted cancer therapy, or certain antibody-based treatments too recently before starting the study (timeframes vary by treatment type — confirm with trial site).
• People living with HIV.
• People with an active hepatitis B or hepatitis C infection detectable through blood tests.
• People with an uncontrolled infection (fungal, bacterial, viral, or other) at the time of the cell collection procedure or the treatment infusion.
• People with another active cancer that requires treatment beyond monitoring or hormone therapy (skin cancers of the squamous or basal cell type are exceptions).
• People who have received immune checkpoint inhibitor treatment within the past 8 weeks.
• People who are currently using herbal supplements.
• People who, in the treating doctor's or lead researcher's judgement, would not be suitable for the study for any other reason.

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