Phase 1 Leukaemia 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 are willing to take part and have given written consent (or whose legal representative has done so on their behalf).
• People aged 18 to 80 years old, of any gender.
• People who are reasonably active and able to care for themselves, with only mild limitations on physical activity (this is measured using a standard scale called the ECOG score of 0 or 1).
• People with a life expectancy of more than 3 months.
• People who have been diagnosed with a type of blood cancer called B-cell Acute Lymphoblastic Leukemia (B-ALL), where the disease has come back or has not responded to treatment — specifically meeting at least one of these situations:
  • The leukemia came back within 12 months of first going into remission with standard treatment
  • The leukemia never went into remission after two or more rounds of standard chemotherapy
  • The leukemia has come back after two or more periods of remission
  • The leukemia came back or did not respond after a stem cell transplant
• People whose leukemia cells have tested positive for a protein called CD19, confirmed by a bone marrow or blood test within the past month.
• People whose bone marrow shows active disease, with at least 5% abnormal blast cells present.
• People with a subtype called Philadelphia chromosome-positive ALL (Ph+ ALL) who have not responded to, or could not tolerate, at least two targeted therapies called tyrosine kinase inhibitors (TKIs), including at least one second-generation TKI — except that people with a specific mutation called T315I do not need to have tried these therapies first (confirm with trial site).
• People with a lymphocyte count (a type of white blood cell) of at least 100 per microlitre of blood.
• People whose liver, kidneys, lungs, and heart are functioning adequately, as confirmed by standard tests (confirm specific thresholds with trial site).
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and agree to use effective contraception for at least one year after receiving the treatment. Men whose partners could become pregnant must agree to use effective barrier contraception for at least one year after receiving the treatment.
• People who have previously received a therapy called blinatumomab must have documentation showing their leukemia cells still carry the CD19 protein after their most recent course of that treatment, with at least 90% of blast cells testing CD19-positive (confirm with trial site).

Who may not be able to join:

• People diagnosed with a specific type of leukemia called Burkitt's leukemia/lymphoma, or chronic myeloid leukemia in an advanced or blast phase.
• People who have had another cancer that has not been in continuous remission for at least 2 years — although some lower-risk cancers (such as certain skin cancers, early-stage solid tumours, treated cervical conditions, or treated localised prostate cancer) may be exceptions (confirm with trial site).
• People who have an active, uncontrolled infection within the 4 weeks before joining the trial.
• People with an active hepatitis B or hepatitis C infection.
• People with HIV infection.
• People who test positive for syphilis.
• People with a severe active autoimmune disease or a condition that affects the immune system — except those with well-controlled Type 1 diabetes or thyroid conditions.
• People who have had a serious allergic reaction to large-molecule biological medicines, such as antibody-based therapies or cytokines.
• People who have taken part in another interventional clinical trial within 4 weeks before joining this trial.
• People with a history of significant brain or nervous system conditions, such as epilepsy, stroke, severe head injury, dementia, Parkinson's disease, or similar conditions.
• People with leukemia that has spread to the fluid around the brain and spinal cord at a moderate or severe level, or with any neurological symptoms related to this involvement (confirm level of CNS involvement with trial site, as some lower levels of involvement may still be eligible).
• People with a history of inherited conditions that affect bone marrow function, such as Fanconi anaemia, Kostmann syndrome, or Shwachman-Diamond syndrome.
• People who have had a significant heart problem in the past 6 months, such as a heart attack, unstable chest pain, heart failure (at a moderate to severe level), or a heart procedure such as stenting or angioplasty.
• People with an active psychiatric illness.
• People with a history of drug abuse or addiction.
• People who have recently received certain medications or treatments, including:
  • Cancer treatments such as chemotherapy, targeted therapies, or blinatumomab taken too recently before the study drug infusion (specific timeframes vary by medication — confirm with trial site)
  • Any previous anti-CD19 treatment other than blinatumomab
  • A severe (Grade 4) neurological reaction or severe immune reaction (Grade 4 cytokine release syndrome) during previous blinatumomab treatment
  • Certain specific chemotherapy agents (alemtuzumab, clofarabine, or cladribine) taken within a recent defined period before the infusion
  • Medications to treat or suppress graft-versus-host disease within 4 weeks before joining
  • Immune checkpoint therapies (such as nivolumab, pembrolizumab, ipilimumab, or similar drugs) without sufficient time having passed since the last dose
  • Radiotherapy to any part of the body within 2 weeks, or to the brain/spinal cord within 8 weeks, before the study drug infusion
  • High-dose steroid treatment (above a prednisone equivalent of 20 mg per day) within 72 hours before the study drug infusion
  • Any previous gene therapy
• People who have moderate to severe graft-versus-host disease (a complication that can occur after a stem cell transplant), or who have needed systemic treatment for this condition within 4 weeks before joining.
• People who have received a live vaccine within 4 weeks before joining the trial.
• People who are pregnant or breastfeeding.
• People who, in the trial doctor's assessment, may have difficulty completing all required visits and procedures, or following the trial requirements.

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