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:

• People who have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or has not responded to previous treatment — with specific prior treatment requirements depending on whether the leukemia carries a genetic marker called the Philadelphia chromosome (confirm with trial site for exact prior treatment requirements)
• People who have given written agreement to participate before any study procedures begin
• People who are at least 17 years old for the first patients enrolled; once safety is confirmed, people aged 12 and older may be eligible to enroll
• People whose leukemia cells test positive for a protein called CD19, if they have previously received treatment that targeted CD19
• People who have previously had a stem cell transplant from a donor, as long as it was at least 3 months before joining the study and there are no signs of a complication called graft-versus-host disease within the 4 weeks before joining
• People who have previously received a type of immune cell treatment called donor lymphocyte infusion, as long as it was at least 4 weeks before a cell collection procedure called leukapheresis
• People who have had leukemia involvement in the fluid around the brain or spine, provided it is not the only site of disease and there are no active neurological symptoms such as seizures, stroke-like symptoms, confusion, speech problems, or psychosis
• People whose liver, kidneys, lungs, and heart are functioning at adequate levels as measured by specific blood and imaging tests at the time of screening
• People who are in reasonably good general health, as measured by standard medical scoring scales
• People who have previously received CD19-targeted treatments (including CAR-T cell therapy or bispecific antibody treatments), as long as CD19 positivity is confirmed on the most recent bone marrow, blood, or biopsy sample

Who may not be able to join:

• People who currently have another active cancer, with some exceptions for certain low-risk or treated cancers such as non-melanoma skin cancer or certain localised solid tumours (confirm with trial site)
• People with a specific type of leukemia/lymphoma called Burkitt's, or chronic myeloid leukemia in a particular advanced stage
• People with leukemia that has spread to the brain or spinal fluid in a way that is visible on scans, is causing symptoms, or meets a specific cell count threshold in spinal fluid — though people whose CNS leukemia has been adequately treated may still be eligible (confirm with trial site)
• People who have taken high-dose steroid medications (above a certain daily dose) within 7 days before leukapheresis or within 72 hours before CAR-T cell infusion
• People who have received systemic chemotherapy less than one week before leukapheresis or CAR-T cell infusion (a specific medication called hydroxyurea may be permitted up to 72 hours before — confirm with trial site)
• People who have had serious heart problems — such as severe heart failure, a heart attack, unstable chest pain, or heart procedures — within the 6 months before screening
• People with a history of significant autoimmune or inflammatory conditions affecting the brain or nervous system
• People who have received treatment for graft-versus-host disease within 4 weeks before joining the study
• People with a known severe autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that is likely to need ongoing immune-suppressing medication
• People living with HIV
• People with an active hepatitis B infection
• People with an active hepatitis C infection
• People with an uncontrolled infection — including fungal, bacterial, viral, or COVID-19 — at the time of leukapheresis or CAR-T cell infusion
• People with other uncontrolled medical or mental health conditions, or personal or logistical circumstances that the trial team determines could interfere with participation
• People who have received a live or attenuated (weakened) vaccine within 4 weeks before leukapheresis
• People who are pregnant or currently breastfeeding

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