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 have been diagnosed with recurring B-cell lymphoma or leukemia (ALL or CLL), or who were newly diagnosed but are unable to receive or complete standard treatment, or who have a form of aggressive B-cell lymphoma that has come back or stopped responding to treatment and whose care plan includes high-dose therapy and a stem cell transplant using their own cells.
• People whose cancer cells test positive for a protein called CD19 (this test result may still be pending at the early stage).
• People aged 75 or younger (the first three people treated in the study must be adults aged 18 or older).
• People whose haemoglobin (a measure of red blood cells) is 7.0 or above, including if reached through a blood transfusion.
• If a blood collection process called pheresis is needed: people whose kidney function, liver enzyme (AST), and blood clotting results are within acceptable ranges (confirm specific values with trial site).
• People whose liver function results are within acceptable ranges at the treatment stage (confirm specific values with trial site).
• People whose kidneys are filtering blood at a rate above 50 mL/min.
• People whose blood oxygen level is above 90% while breathing normal room air.
• People who score above 60% on a general health and ability scale (confirm with trial site).
• People who have recovered from the side effects of any previous chemotherapy at least one week before joining the study.
• People for whom a suitable T-cell product (a specially prepared immune cell product used in the treatment) has been successfully made and meets the required quality level.
• People with a life expectancy of more than 12 weeks.
• People who are sexually active and are willing to use effective contraception during the study and for 6 months afterwards (male partners should also use a condom).
• People, or their legal guardians, who have read, understood, and signed the informed consent form.

Who may not be able to join:

• People who currently have an active infection that requires antibiotic treatment.
• People who have a history of another cancer (other than certain skin cancers or early-stage breast or cervical cancer) unless that cancer was successfully treated with the aim of a cure at least 2 years before joining the trial.
• People who are currently taking part in another research study or who have received a cancer vaccine within the past 6 weeks (note: treatment with certain immunotherapy drugs called PD1/PDL1 inhibitors is allowed).
• People who have previously had a serious allergic reaction to products containing mouse-derived proteins.
• People who are pregnant or breastfeeding.
• People whose tumour is located in a place where any swelling could block the airway.
• People who have an active HIV or HTLV infection.

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