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:

• The person joining (or their guardian) must understand and voluntarily sign a consent form before taking part
• People aged 12 to 65 years old at the time of signing the consent form (both males and females)
• People whose doctors expect them to live for at least 12 weeks
• People who are relatively physically well and able to carry out daily activities, as measured by a standard performance scale score of 0 or 1 (confirm with trial site)
• People who have been diagnosed with B-cell acute lymphoblastic leukaemia (a type of blood cancer) that has come back or stopped responding to treatment, and who meet at least one of the following: the cancer came back within 12 months of first going into remission, the cancer has come back two or more times, the cancer never responded to at least two rounds of initial treatment, or the cancer did not respond to at least one round of treatment after the first relapse
• People whose cancer is a type linked to a specific gene change (called Philadelphia chromosome-positive ALL) and who have already tried at least two targeted medicines called tyrosine kinase inhibitors (TKIs) without success — unless they have a specific mutation called T315I — or who were unable to tolerate or use those medicines
• People whose bone marrow test at screening shows more than 5% of abnormal early-stage cancer cells
• People whose cancer cells (in bone marrow or blood) test positive for a protein called CD19 at screening
• People whose liver, kidney, and other major organs are functioning well enough to meet specific test result thresholds set by the trial (confirm with trial site for exact values)
• People whose blood oxygen level is above 92%
• People of childbearing age who agree to use effective contraception from the time of signing the consent form until two years after receiving the study treatment, and females of childbearing age must have a negative blood pregnancy test at screening

Who may not be able to join:

• People whose cancer has returned only outside the bone marrow (called isolated extramedullary relapse)
• People diagnosed with a specific type of fast-growing cancer called Burkitt's lymphoma or leukaemia
• People with a history of significant brain or nervous system conditions, such as epilepsy, stroke, dementia, Parkinson's disease, paralysis, or serious brain injury — except for leukaemia that has spread to the brain but is no longer active
• People who have previously had a stem cell transplant
• People who have been treated with medicines that suppress the immune system for an autoimmune disease (such as rheumatoid arthritis, lupus, or Crohn's disease) within the two years before signing the consent form
• People with any active infection that is not under control at the time of consent or within four weeks before a cell collection procedure, and that requires antibiotic, antiviral, or antifungal treatment
• People who have previously received any cell therapy that targeted the CD19 protein
• People who have previously received CAR-T therapy or any other cell or gene therapy
• People who test positive at screening for certain infections, including active hepatitis B, hepatitis C (with detectable virus), HIV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), or syphilis — specific testing rules apply (confirm with trial site)
• People with significant heart problems, including a specific irregular heart rhythm reading on an ECG, moderate-to-severe heart failure, unstable chest pain or heart attack within the past six months, low heart pumping function, poorly controlled high blood pressure, or certain serious heart rhythm problems
• People who are allergic to any ingredient in the study drug or the preparatory medicines used in this trial
• People who have received any other study drug or systemic cancer treatment within four weeks (or five half-lives of the drug) before the cell collection procedure
• People who have had extensive radiation therapy within four weeks before signing the consent form (limited local radiation for symptom relief may be allowed — confirm with trial site)
• People who still have side effects from previous cancer treatments that have not returned to a mild or baseline level by the time of consent (hair loss and skin colour changes are exceptions)
• People who need to take higher-dose steroid medicines or other immune-suppressing drugs within two weeks before consent or before the cell collection procedure, or during the study — certain low-dose or localised steroid uses may be allowed (confirm with trial site)
• People who have had major surgery within four weeks before signing the consent form, or who are expected to need major surgery during the trial (routine biopsy is not included in this restriction)
• People with a history of active tuberculosis within the past year — those with a history of tuberculosis more than one year ago may be assessed individually by the trial doctor
• People with thyroid problems that the trial doctor considers clinically significant
• People who have or have had a lung condition involving scarring or inflammation of lung tissue (interstitial lung disease or interstitial pneumonia)
• People who have had another separate cancer diagnosis within the past five years — except for certain early-stage or fully treated skin cancers, or a fully treated early form of cervical cancer
• People who have received a live-attenuated or inactivated vaccine within four weeks before signing the consent form, or who plan to receive one during the screening period
• People whose overall health, other medical conditions, or circumstances make participation inappropriate in the trial doctor's judgement
• People who are pregnant or breastfeeding

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