Early 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 aged 18 to 75 years (inclusive), of any gender.
• People whose general health and ability to carry out daily activities meets a minimum score on a standard medical rating scale (Karnofsky Performance Status score of 70 or above).
• People with a life expectancy of at least 12 weeks, as estimated by their doctor.
• People whose cancer cells have tested positive for a protein called CD19, confirmed by a specialised blood or bone marrow test called flow cytometry.
• People who have been diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL), confirmed by bone marrow examination, AND who also meet at least one of the following:
  • The leukemia did not go into remission after two rounds of standard initial chemotherapy, or did not respond to further chemotherapy attempts.
  • The leukemia came back within 12 months of first going into remission, or came back after further chemotherapy attempts.
  • The leukemia came back after a stem cell transplant (either using the patient's own cells or a donor's cells).
  • For people whose leukemia carries a specific genetic feature called the Philadelphia chromosome: at least two different targeted treatments (called tyrosine kinase inhibitors, or TKIs) have not worked, or the person could not tolerate those treatments, or the cancer carries a specific mutation (called T315I) that makes it resistant to those treatments.
• People whose bone marrow examination shows more than 5% abnormal (blast or immature) cells.
• People who have not had a stem cell transplant within the 6 months before joining the trial.
• People whose kidneys, liver, heart, and lungs are functioning at acceptable levels, as defined by all of the following:
  • Kidney function (measured by a calculation called creatinine clearance) above 60 mL/min.
  • Liver enzyme levels (ALT and AST) below 2.5 times the normal upper limit (or up to 5 times the normal upper limit for people with liver involvement from their cancer).
  • A blood chemical called total bilirubin below 1.5 times the normal upper limit (or up to 3 times the normal upper limit for people with a specific inherited condition called Gilbert's syndrome).
  • A minimum level of a type of white blood cell (lymphocytes) in the blood of at least 0.1 × 10⁹/L.
  • The heart's pumping function (left ventricular ejection fraction) above 50%, with no significant fluid around the heart, confirmed by an ultrasound of the heart.
  • No significant fluid build-up around the lungs.
  • Blood oxygen levels above 92% while breathing normal room air.
• Women who could become pregnant must not be breastfeeding, must have a negative pregnancy test at screening, and must use an accepted form of contraception throughout the treatment period and for 2 years after the first treatment. Men who could father a child must not donate sperm during this same period.
• People who are able to communicate with the research team, are willing to follow the study requirements, complete all required procedures, and sign a consent form (either themselves or through a legal guardian).

Who may not be able to join:

• People whose leukemia exists only outside the bone marrow (isolated extramedullary leukemia), or who have relapsed only in areas outside the bone marrow.
• People whose leukemia has spread to the central nervous system at a specific stage called CNS2.
• People with a history of another type of cancer, unless it was one of the following that has been fully treated: certain non-melanoma skin cancers, early-stage cervical cancer, localised prostate cancer, certain early bladder cancers, a non-invasive breast condition called ductal carcinoma in situ, or any other cancer where the person has been cancer-free for more than 5 years.
• People who test positive for certain infectious diseases, including HIV, hepatitis C (HCV), a hepatitis B surface protein (HBsAg), a combination of a hepatitis B antibody and detectable hepatitis B virus in the blood, or syphilis (TPPA).
• People who received a live or weakened live vaccine within 4 weeks before joining the trial.
• People with Philadelphia chromosome-positive leukemia who received a targeted treatment called a tyrosine kinase inhibitor (TKI) within 1 week before joining the trial.
• People who have previously received any treatment that targets the CD19 protein, CAR-T cell therapy, or other gene-edited T cell therapies.
• People who, within 4 weeks before joining the trial, experienced a significant immune reaction after a stem cell transplant (called graft-versus-host disease, or GVHD) at a moderate-to-severe level requiring treatment, or had an extensive chronic form of GVHD; or people whose doctor thinks they may need GVHD treatment during the study.
• People who, in their doctor's judgement, would need ongoing steroid or other immune-suppressing medicines during the study; or people who received a type of immune cell therapy called donor lymphocyte infusion (DLI) within 4 weeks before joining the trial.
• People who received radiation therapy directed at the brain or spinal cord within 4 weeks before joining the trial.
• People who still have unresolved side effects from a previous treatment (not including blood count changes or hair loss) that have not improved to a mild level or resolved.
• People with a known serious allergy or intolerance to the study drug, or a history of severe allergic conditions.
• People with active autoimmune diseases (such as lupus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, or Hashimoto's thyroiditis, among others) — except for an underactive thyroid that is managed only with hormone replacement.
• People who had major surgery requiring general anaesthesia within 4 weeks before joining the trial, have not fully recovered from a previous surgery, or are expected to need major surgery during the study.
• People who took part in another clinical drug trial within 28 days before joining this trial.
• People who have had a significant heart condition within the 6 months before joining the trial, including unstable chest pain, heart attack, moderate-to-severe heart failure, serious heart rhythm problems requiring medication, or certain heart procedures such as stenting or bypass surgery.
• People with a history of brain or nervous system conditions (such as seizures, stroke, dementia, or balance-related brain disorders), or any autoimmune disease affecting the brain or nervous system.
• People with an active, uncontrolled infection at the time of screening (such as a serious blood infection or widespread infection throughout the body).
• People whom the trial doctor considers unsuitable for any other reason.

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