Phase 1 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 have a history of B precursor acute lymphoblastic leukaemia (a type of blood cancer) AND meet at least one of the following: the cancer has come back two or more times; it came back after a bone marrow transplant from a donor; it came back or did not respond after a CAR T cell therapy that targeted a single antigen (at least 90 days must have passed since that CAR T cell infusion); it has not responded to standard treatments as decided by the treating doctor; or the patient and/or their parents have declined a bone marrow transplant and prefer CAR T cell therapy.
• The cancer cells must have shown certain markers called CD19 and/or CD22 at the most recent assessment.
• The patient must have a reasonable level of physical functioning, as measured by standard medical scoring tools (confirm with trial site).
• The patient must be eligible for, or have already had, a blood cell collection procedure called leukapheresis.
• Male patients, or female patients who are not pregnant and not breastfeeding.
• Patients aged 3 months to 30 years old at the time of enrolment.
• A signed consent form must be provided — by a parent or guardian for patients under 18, by the patient themselves if over 18, or by a legally authorised representative if the patient is over 18 but unable to make decisions for themselves.
• The patient must be willing to follow all study procedures for the full duration of the study.
• The patient must be willing to take part in long-term follow-up after the trial.

Who may not be able to join:

• People with active, uncontrolled leukaemia in the brain or spinal cord that is getting worse or causing symptoms such as seizures, weakness, speech problems, bleeding, or movement difficulties, as determined by the treating doctor.
• People who have had a donor stem cell transplant and it has been fewer than 100 days since the transplant, OR there are signs of a serious reaction called graft-versus-host disease that requires medication, OR it has been fewer than 6 weeks since a donor lymphocyte infusion.
• People with a serious, active, life-threatening infection that the treating doctor believes would make the procedures unsafe.
• People with severe organ problems, including: blood oxygen levels below 90% while breathing normal air; significant heart problems including poor pumping function or fluid around the heart; liver enzyme or bilirubin levels well above the normal range (unless caused by the cancer itself); or kidneys not filtering blood well enough.
• People of childbearing or child-fathering potential who are not willing to use birth control from enrolment through to 12 months after receiving the study treatment.
• People with a known HIV infection, or an active Hepatitis B or Hepatitis C infection.

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