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:

For patients (to enter the study):

• People aged 6 months to 80 years
• People who are planning to have, or have already had, a stem cell transplant from a donor (either full-strength or reduced-strength conditioning)
• People diagnosed with high-risk AML (a type of blood cancer) or MDS (a bone marrow disorder) who have had or will have a donor stem cell transplant, and whose cancer has not come back in the blood
• People with a functional ability score of at least 50 out of 100 on standard medical scales (meaning able to carry out some self-care activities)
• People who agree to use contraception during the study, when this applies to their age
• People, or their parent or guardian, who are able to give informed consent to participate
• People whose blood test results show that more than 94% of their T cells (a type of immune cell) come from the donor

For patients (before receiving the study treatment, called TAA-T):

• People with high-risk AML or MDS who have had a donor stem cell transplant and whose cancer has not returned in the blood
• People taking low-dose steroids (below a certain threshold) with no increase in treatment in the past two weeks
• People with a functional ability score of at least 50 out of 100
• People whose liver and kidney function blood test results are within acceptable ranges
• People whose blood oxygen level is above 90% while breathing normal room air
• People with a sufficient level of infection-fighting white blood cells (support medication may be allowed)
• People who agree to use contraception during the study, when this applies to their age
• People, or their parent or guardian, who are able to give informed consent
• People with adequate heart function based on a scan done within the last 6 months, if they received a certain level of radiation therapy (confirm with trial site)
• People whose blood cell mix shows enough donor cells — either more than 50% overall, or more than 50% donor T cells if cancer cells affect the overall result (tested within the last 6 months)

For donors:

• Donors for the stem cell transplant who have completed standard eligibility checks as required by US regulatory guidelines
• Donors aged 6 months to 80 years
• Donors, or the guardian of a child donor, who are able to give informed consent
• Donors who have completed a specific set of infectious disease blood tests within 7 days before or after blood is collected for making the study treatment
• Female donors of childbearing age who have a negative pregnancy test within 7 days of blood collection for the study treatment

Who may not be able to join:

For patients (entering the study):

• People with infections that are not currently under control
• People experiencing moderate to severe graft-versus-host disease (a condition where donor cells attack the body) above a certain severity level, or certain chronic forms of this condition
• People who are pregnant

For patients (before receiving TAA-T treatment):

• People who have received certain immune-suppressing medications (including ATG, Campath, or similar antibody treatments) within the past 28 days
• People who have received other experimental treatments (under investigational status) within the past 28 days
• People with infections that are not currently under control
• People with active chronic graft-versus-host disease affecting the lungs, skin, or lining of organs
• People with active graft-versus-host disease of any grade that has required an increase in treatment in the past two weeks (this applies specifically to one group within the trial — confirm with trial site)
• People who are pregnant or breastfeeding
• People who have had, or are planning to have, a second donor stem cell transplant

For donors:

• Donors for whom giving cells would carry a physical or psychological risk
• Female donors of childbearing age who are known to be pregnant

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