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 the cell donor (a family member):

• The donor must be 18 years of age or older
• The donor must be a family member who is at least a partial match (at least 3 out of 6 markers) with the patient
• The donor must test negative for HIV
• Female donors of childbearing age must not be pregnant (confirmed by a negative pregnancy test within 14 days before joining) and must not be currently breastfeeding or planning to breastfeed
• The donor must have completed all required donor health and safety checks as outlined by US federal regulations

For Cohort A donors specifically: A recipient must have been identified who has leukemia that has come back or has not responded to treatment, and whose cancer cells carry a marker called CD19

For Cohort B donors specifically: A recipient must have been identified who has leukemia that has come back or has not responded to treatment with CD19 markers, and who is not a suitable candidate for a type of treatment that uses their own modified immune cells, for one of these reasons:

• The leukemia came back or did not respond after already receiving that type of treatment using their own cells
• A previous attempt to collect enough of their own cells for that treatment was not successful
• A previous attempt to manufacture that treatment using their own cells was not successful
• The treating doctor considers the patient unable to undergo the cell collection process (for example, due to small body size, low cell counts, rapidly progressing disease, or general health status)

For the patient receiving treatment:

• The patient must be 21 years of age or younger
• The patient must have leukemia with CD19-positive cancer cells that has either returned or has not responded to treatment, meeting one of the following:
  • The leukemia did not respond to at least 2 rounds of intensive chemotherapy aimed at achieving remission
  • The leukemia did not respond to follow-up (salvage) treatment after an initial course of therapy
  • The leukemia has relapsed two or more times
  • The leukemia has relapsed at any point after a bone marrow or stem cell transplant from another person
  • The leukemia has relapsed for the first time and a stem cell transplant from another person would normally be the recommended next step, but the patient has been found to be unsuitable for that transplant
• CD19-positivity in the cancer cells must have been confirmed within the past 2 months, including after any treatment that targeted CD19
• Patients in Cohort A must have previously received a stem cell or bone marrow transplant from the same family member who will be donating cells for this trial
• Patients in Cohort B must not have previously received a stem cell or bone marrow transplant from the selected donor, and must also be unsuitable for the type of treatment using their own modified immune cells (as described above in the donor section)
• Leukemia must still be detectable in the bone marrow at the time of joining the trial
• The patient's life expectancy must be at least 8 weeks
• The patient must have a performance score of 50 or above on a standard medical scale used to measure ability to carry out daily activities (confirm with trial site)
• The leukemia must not have spread to the central nervous system (brain and spinal cord) in a way that is causing neurological symptoms
• If the patient has previously had a stem cell or bone marrow transplant from another person, they must meet all of the following before receiving the trial treatment:
  • At least 3 months must have passed since that transplant
  • The patient must have recovered from the effects of that transplant
  • There must be no sign of graft-versus-host disease (a complication where donor cells attack the body) in the past 2 months
  • The patient must not have received a donor immune cell infusion (DLI) in the 28 days before the planned trial treatment
• The patient must have adequate heart function, as measured by specific tests (confirm with trial site for exact thresholds)
• The patient must have a normal heart rhythm reading on an ECG (heart trace test), with no signs of a significant irregular heartbeat
• The patient must have adequate kidney function, as measured by specific tests (confirm with trial site for exact thresholds)
• The patient must have adequate lung function, either measured by a breathing test or by a blood oxygen level of 92% or above while breathing normal room air
• Liver blood test results must be within acceptable ranges for the patient's age (with an exception for people with a condition called Gilbert's syndrome)
• The patient must have no history of HIV infection
• The patient must not have a severe, uncontrolled bacterial, viral, or fungal infection at the time of joining
• The patient must have recovered from any serious side effects from previous treatments
• Female patients of childbearing age must not be pregnant (confirmed by a negative pregnancy test within 7 days before joining) and must not be currently breastfeeding or planning to breastfeed
• Patients who are sexually active must agree to use contraception until at least 6 months after receiving the trial treatment
• The patient must have no history of allergic reactions to products that contain mouse-derived proteins
• The patient must not be receiving high-dose steroid medications (above a specified level) within 7 days before the planned trial treatment
• The patient must not be receiving any systemic treatment within 14 days before the planned trial treatment that the treating doctor considers likely to interfere with how the trial treatment works
• The patient must not have received chemotherapy injected into the spinal fluid within 7 days before the planned trial treatment

Who may not be able to join:

• No formal exclusion criteria were listed separately in the official trial document — all eligibility requirements are described above (confirm with trial site)

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