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 who meet the medical requirements for a blood cell collection procedure (called leukapheresis), or who have already had cells collected and stored according to recommended guidelines.
• People (or their parent, guardian, or legal representative) who are willing and able to sign and date a consent form; children over 7 years old will also be asked for their own agreement to participate where appropriate.
• People who are willing to take part in a long-term follow-up study after the trial.
• People who are willing to follow all study procedures and remain available for the full duration of the study.
• Males, or females who are not currently pregnant or breastfeeding; people who could become pregnant or father a child must agree to use highly effective contraception from the time of the first treatment through to 12 months after the last dose.
• People aged 31 days to 30 years old (inclusive) at the time of joining the trial.
• People diagnosed with B-cell Acute Lymphoblastic Leukaemia (ALL) or B-cell Non-Hodgkin Lymphoma (NHL) where testing has confirmed the cancer cells carry a marker called CD19.

For the first group (Cohort One), people must also meet at least one of the following:

• The cancer has come back two or more times.
• The cancer came back at any point after a bone marrow transplant.
• The cancer has not responded to standard treatments, as determined by the treating doctor.
• The person meets the medical criteria for a bone marrow transplant but has been assessed by their treating doctor as unable to have one, or the person and/or their family have chosen not to pursue a bone marrow transplant and would prefer CAR-T cell therapy.
• For Non-Hodgkin Lymphoma specifically, the diagnosis must be one of the following types: Diffuse large B-cell lymphoma (DLBCL), Burkitt Lymphoma, intermediate lymphoma between Burkitt and DLBCL, Primary Mediastinal B-cell Lymphoma, Follicular lymphoma, High grade B-cell lymphoma, or Transformed lymphoma.

For the second group (Cohort Two), people must meet one of the following:

• B-cell ALL that has come back for the first time, and at the time of original diagnosis the cancer had certain high-risk genetic features (such as specific gene changes or mutations — confirm details with the trial site).
• B-cell ALL that has come back only in the fluid and tissues around the brain and spine, where standard treatment would normally include radiation to the head.
• B-cell ALL that has come back for the first time in a person who has Down syndrome.
• B-cell ALL that has come back for the first time, and after re-induction chemotherapy, a very sensitive test still detects a small number of leukaemia cells in the bone marrow above a certain level (confirm specifics with trial site).
• B-cell ALL that has come back for the first time in a person aged 18 years or older.
• Newly diagnosed B-cell ALL where, after a phase of treatment called consolidation, a sensitive test still finds leukaemia cells in the bone marrow above a certain threshold.
• A functional ability score (measured by standard medical scales) of 50% or better, meaning the person is able to manage at least some daily activities.
• People for whom commercially available CD19 CAR-T therapy is not an option, or who have chosen not to receive it.

Who may not be able to join:

• People whose cancer is progressing very rapidly and who do not have adequate treatment to stabilise it beforehand, as assessed by the study investigator.
• People who currently have active Graft-versus-Host Disease (a complication that can occur after a bone marrow transplant, where donor cells attack the body).
• People with a serious, uncontrolled, life-threatening infection that the treating doctor believes would make the cell collection procedure, pre-treatment chemotherapy, cell infusion, or potential side effects unsafe.
• People with severe heart problems, including significantly reduced heart pumping function, a medically significant fluid build-up around the heart, or clinically significant abnormal heart rhythm findings.
• People whose blood oxygen level is 90% or below while breathing normal room air.
• People with significantly elevated liver enzyme or bilirubin levels in blood tests, unless these are believed to be directly caused by the underlying cancer.
• People whose kidneys are not filtering blood at an adequate rate, based on testing (confirm specifics with trial site).
• Females past puberty who are pregnant, planning to become pregnant, or unwilling to use contraception (including abstinence) for the duration of the study.
• People with a known HIV infection, or a currently active Hepatitis B or Hepatitis C infection.

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