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:

• You have been diagnosed with B-cell Acute Lymphoblastic Leukemia (a type of blood cancer) that has come back or has not responded to treatment, and your cancer cells test positive for certain proteins called CD19, CD20, and/or CD22.
• You are between 1 and 25 years old.
• Your doctors expect you to live for at least 8 weeks.
• You weigh at least 10 kg (about 22 pounds).
• You are able to give consent yourself (if 18 or older), or a parent or legal guardian can give consent on your behalf (if under 18); adults with cognitive impairment or Down's syndrome may also be eligible with appropriate consent arrangements.
• You have stopped certain cancer treatments for a required period of time before the cell collection step — the exact waiting period depends on the type of treatment (confirm with trial site for your specific medications).
• Your cancer meets specific conditions about how it has returned or not responded — for example, it has relapsed more than once, came back after a bone marrow transplant, or did not respond to at least two rounds of treatment.
• The specially prepared T-cells made from your own blood must meet a minimum quality standard (at least 15% of the cells must carry the required cancer-targeting protein).
• Your liver is working well enough, based on blood test results within accepted ranges for your age.
• Your kidneys are working well enough, based on blood test or kidney function results within accepted ranges for your age and gender.
• Your blood oxygen level is at least 90% while breathing normal room air.
• Your heart is pumping well enough, confirmed by a heart scan (echocardiogram or similar test).
• Your general ability to carry out daily activities meets a minimum score on a standard scale used for children or adults (confirm with trial site).
• If you previously had a donor lymphocyte infusion (a type of immune cell treatment), it was completed more than 6 weeks before the planned treatment.
• If you are able to have children or father children, you agree to use highly effective contraception from the time of your first treatment until 12 months after your last treatment.
• You are willing to take part in long-term follow-up monitoring for up to 15 years.

Who may not be able to join:

• You have another active cancer besides the B-cell leukemia being studied.
• You have a serious active infection, such as a positive blood culture within the last 48 hours, or a known active infection with HIV, hepatitis B, hepatitis C, or HTLV.
• You have a primary immune deficiency disorder (a condition where your immune system does not work properly from birth).
• You are currently pregnant or breastfeeding.
• You have any other condition that, in the doctor's opinion, would make it unsafe for you to take part in this trial (confirm with trial site).
• If you previously had a bone marrow/stem cell transplant from a donor, you currently have active graft-versus-host disease (a complication where donor cells attack your body) of a certain severity, or you are still taking medications to manage or prevent it within the last 4 weeks.
• You currently have serious active neurological (brain or nervous system) problems requiring medical treatment, such as stroke, severe brain injury, or significant movement or thinking difficulties; however, some stable, well-controlled conditions such as a seizure disorder with no seizures in the past 3 months may still be eligible (confirm with trial site).

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