Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the 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 with a type of blood cancer called CD5+ T-cell malignancy that has come back or stopped responding to treatment, where standard treatments have either been tried or were not tolerated, and no curative options (such as stem cell transplant or chemotherapy) are available.
• For people who previously received a specific type of cell therapy (autologous CD5 CAR T cells), the cancer cells in the blood must make up less than 20% of blood cells, and any cancer-fighting treatment must have been paused for more than 2 weeks.
• People aged between 1 and 70 years old.
• People with no history of severe allergic reactions.
• People who are reasonably active and able to care for themselves, based on a standard medical scoring system (rated 0 to 2 on the ECOG scale).
• People who are expected to live for at least 60 days.
• People whose cancer cells test positive for the CD5 marker at a high enough level, confirmed through laboratory testing of bone marrow, spinal fluid, or tumour tissue.
• People (or their legal guardians, for younger children) who are able to understand and sign a consent form agreeing to take part and follow the study schedule — with specific consent rules depending on age.
• People who have a matching stem cell donor available, if they are planned to receive a newly matched donor-derived CD5 CAR T cell treatment, and who are willing to undergo a stem cell transplant if the treatment is successful.

Who may not be able to join:

• People with reduced consciousness or increased pressure in the brain.
• People with significant heart failure or a serious irregular heartbeat.
• People with severe breathing or lung problems.
• People who have another type of cancer at the same time.
• People with a serious blood clotting disorder called disseminated intravascular coagulation.
• People whose kidney function tests (creatinine and/or BUN) are significantly above the normal range.
• People with an active, uncontrolled infection such as sepsis.
• People with diabetes that is not well controlled.
• People with a serious mental health condition.
• People who have active lesions or abnormalities in the brain shown on an MRI scan.
• People who have previously had an organ transplant (other than a stem cell transplant).
• People who are pregnant.
• People who test positive for hepatitis, HIV/AIDS, or syphilis.
• People who are planned to receive newly matched donor-derived CD5 CAR T cells but for whom a follow-up stem cell transplant would not be possible.
• People from whom the specific blood cells needed to make CAR T cell therapy cannot be collected or are not already stored.

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