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:

• Adults aged 18 to 65 years old
• People who have acute lymphoblastic leukemia (ALL) that has come back or has not responded to treatment, meeting at least one of these situations: the leukemia came back within 12 months of first going into remission; the leukemia did not go into remission after more than 6 weeks of initial chemotherapy or after 2 rounds of initial chemotherapy; the leukemia has relapsed in the bone marrow two or more times; the leukemia came back after chemotherapy and did not respond to at least one rescue treatment; or the leukemia came back in the bone marrow after a stem cell transplant
• People whose leukemia cells have a protein called CD19 on their surface, confirmed by a bone marrow or blood test within the last 3 months
• People with a specific type of ALL called Philadelphia chromosome positive (Ph+) ALL, who have either not tolerated or have not responded to two types of targeted therapy drugs (called TKIs), or who have a specific genetic change called T315I mutation (confirm with trial site)
• People whose bone marrow contains at least 5% leukemia cells at the time of screening
• People who are in generally good physical condition, able to carry out normal daily activities (rated 0 or 1 on a standard medical scale)
• People whose liver, kidney, lung, and blood clotting function all meet specific health thresholds as assessed by the trial team
• People whose veins are suitable for a blood collection procedure called apheresis
• Women of childbearing potential who have a negative pregnancy test within 3 days before the apheresis and treatment procedures, and who agree to use highly effective contraception during the study and for at least 2 years after treatment; male participants must also agree to use highly effective contraception for the same period
• People who have given their signed informed consent to participate

Who may not be able to join:

• People whose leukemia has spread to the central nervous system (brain and spinal cord)
• People whose leukemia has relapsed only outside the bone marrow, with no bone marrow involvement
• People who have received most types of chemotherapy within 2 weeks before the treatment infusion (specific exceptions and timing rules apply for certain drugs — confirm with trial site)
• People who have received radiation therapy to non-brain areas less than 2 weeks before the infusion, or radiation to the brain or spine less than 8 weeks before the infusion
• People who have taken high-dose steroid medications that were stopped less than 72 hours before the treatment infusion (low replacement doses may be allowed — confirm with trial site)
• People who have received a total lifetime dose of certain heart-affecting chemotherapy drugs (such as doxorubicin or daunorubicin) that exceeds guideline-recommended limits, as assessed by the trial team
• People who have previously received any CAR-T cell therapy
• People who have had a serious immune reaction after a stem cell transplant (called graft-versus-host disease) within 4 weeks before screening, or who have received medication for this condition within 4 weeks before the treatment infusion
• People with a condition called systemic vasculitis (widespread inflammation of blood vessels)
• People with certain active or detectable viral infections, including active hepatitis B, hepatitis C, syphilis, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) (confirm with trial site for specific test thresholds)
• People with a history of another cancer, unless that cancer has been fully treated and in remission for 5 or more years with a low risk of returning, as judged by the trial team
• People with significant heart problems, including weak heart pumping function, severe heart failure, serious irregular heartbeat, uncontrolled high blood pressure, unstable chest pain, a heart attack or heart surgery within the past 6 months, significant heart valve disease, or other heart conditions the trial team considers unsuitable
• People with a significant build-up of fluid around the lungs
• People with a history of epilepsy (seizures), stroke, bleeding in the brain, or other active brain or nervous system conditions
• People who have had a blood clot in a deep vein or in the lungs within the past 6 months
• People with a known allergy to any ingredient used in the treatment
• People who have received a live vaccine within 6 weeks before screening
• People who have an active infection at the time of screening
• People whose life expectancy is estimated to be less than 3 months
• People who are currently participating in another interventional clinical trial or who have received an unlisted experimental drug within 3 months before the treatment infusion, or a marketed drug within a specific timeframe (confirm with trial site)
• People who have any other condition that the trial team considers would make participation unsuitable

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