Phase 2 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 aged 19 years or older who are willing to take part and sign a written consent form.
• People who have been diagnosed with a specific type of B-cell lymphoma (either primary central nervous system lymphoma of the DLBCL subtype, or DLBCL that has spread to the brain or spinal cord only) that has come back or stopped responding to treatment, confirmed by tissue testing under the 2017 WHO classification system.
• People whose lymphoma did not respond to a previous treatment that included high-dose methotrexate, or who were unable to tolerate that treatment.
• People who agree to provide a tumour tissue sample — either a stored sample collected within the last 6 months (with no cancer treatment given after it was collected), or a new sample taken during the screening period; if a biopsy is considered medically unsafe by the doctor, enrolment may still be considered in consultation with the treating physician.
• People whose general health and ability to carry out daily activities falls within an acceptable range on a standard medical scale (ECOG performance status score of 2 or lower) at the time of screening.
• People whose kidney and liver function test results fall within the acceptable ranges specified by the trial (confirm with trial site for exact values).
• People whose blood counts (red blood cells, white blood cells, platelets, and lymphocytes) are within acceptable ranges based on a blood test taken within 2 weeks before screening, without having needed a recent blood transfusion.
• People whose heart is functioning well at the time of screening — specifically, no signs of fluid around the heart and a heart pumping strength (left ventricular ejection fraction) of 50% or higher, confirmed by a heart scan.
• People from whom enough cells can be collected through a blood filtering process (leukapheresis) to make the study treatment called Anbal-cel.
• People whose life expectancy is at least 12 weeks.
• People who agree to attend all required clinic visits, tests, and follow-up appointments as set out in the trial plan.
• Women who could become pregnant, and men, who agree to use effective contraception for at least 12 months after receiving Anbal-cel, and until the treatment is no longer detectable in testing.

Who may not be able to join:

• People who have previously had a stem cell transplant using cells from another person (allogeneic transplant).
• People with a history of another cancer (other than B-cell non-Hodgkin lymphoma) within the past 3 years — though some early-stage or fully treated skin, thyroid, prostate, cervical, or stomach cancers may be considered acceptable if the doctor is satisfied the person has been fully cured.
• People who have had unstable chest pain (angina) or a heart attack within the past 12 months.
• People who have had a blood clot, pulmonary embolism (clot in the lungs), or a bleeding disorder within the past 6 months.
• People who have had low oxygen levels, significant fluid around the lungs, or abnormal heart rhythm test (ECG) results within the past 6 months.
• People who are known to be HIV positive.
• People who have an active autoimmune or inflammatory disease affecting the nervous system (such as Guillain-Barré syndrome or ALS).
• People who have had recurring or symptomatic dangerous heart rhythm problems that have not been controlled by treatment in the 3 months before screening.
• People whose disease is considered to be rapidly getting worse, as assessed by the trial doctor.
• People who have had major surgery requiring general anaesthesia or breathing support within the past 4 weeks before screening (some minor surgical procedures within the past 2 weeks may still be acceptable — confirm with trial site).
• People who have a serious infection requiring antibiotic, antifungal, or antiviral treatment at the time of screening, or who have an active infection that is not under control.
• People who have taken part in another clinical trial or used another experimental drug or device within the past 4 weeks.
• People who are pregnant or breastfeeding.
• People who have a known allergy or sensitivity to any ingredient in the study treatment.

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