Phase 1 Lymphoma 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:

Cohort A (adults with B cell lymphoma):

• People aged 18 or older at the time of signing the consent form
• People who are willing and able to sign a consent form agreeing to take part
• People who have been diagnosed with one of the following types of B cell lymphoma that has come back or stopped responding to treatment: diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma, high grade B cell lymphoma with certain gene changes (MYC and BCL2 and/or BCL6), primary mediastinal large B-cell lymphoma, aggressive B cell lymphoma that developed from a slower-growing lymphoma, or mantle cell lymphoma
• People whose cancer has come back or stopped responding after at least 2 previous treatments, OR has come back after a stem cell transplant (using their own or a donor's cells), OR has come back after CAR-T cell therapy
• People whose heart, kidneys, and liver are functioning well enough to meet specific medical thresholds set by the trial (confirm with trial site)
• People who are well enough to carry out basic daily activities, as measured by a standard health scoring tool (confirm with trial site)
• People who are able to become pregnant, or sexually active males whose partners could become pregnant, who agree to use highly effective contraception for at least one year after receiving the trial treatment
• People with a tumour that can be reached for a biopsy, who are willing to have one taken at enrolment — or who have had a biopsy within the past 3 months that can be used instead

Cohort B (children, adolescents, and young adults with B cell leukaemia):

• People between the ages of 1 and 39 at the time of signing the consent form
• For participants too young to consent on their own, a parent or legal guardian must provide consent, and the participant's agreement must also be obtained where applicable
• People who have been diagnosed with B cell acute lymphoblastic leukaemia (B-ALL) that has come back or stopped responding to treatment
• People whose cancer has come back or stopped responding after at least 2 previous treatments, OR has come back after a stem cell transplant, OR has come back after CAR-T cell therapy
• People in this cohort, or those who have previously received therapy targeting a protein called CD22, must have a test result from within the past 6 months confirming their cancer cells carry CD22 (confirm with trial site)
• People whose heart, kidneys, and liver are functioning well enough to meet specific medical thresholds set by the trial (confirm with trial site)
• People who are well enough to carry out basic daily activities, as measured by a standard health scoring tool (confirm with trial site)
• People of reproductive age who agree to use highly effective contraception for at least one year after receiving the trial treatment
• People who are willing to have a bone marrow biopsy taken at enrolment

Who may not be able to join:

• People who have a serious or uncontrolled active infection at the time of enrolment
• People who have an active autoimmune disease that has required immune-suppressing medication within the 4 weeks before enrolment
• People who have received a live vaccine within 6 weeks before enrolment
• People who have active graft-versus-host disease (a complication sometimes seen after donor stem cell transplants) requiring immune-suppressing medication within the 4 weeks before enrolment
• People who have been diagnosed with lymphoma that originated in the brain or spinal cord (primary central nervous system lymphoma)
• People who have received certain treatments too recently before the blood collection procedure used to make the trial therapy, including: a donor or own stem cell transplant within 3 months, CAR-T cell therapy within 3 months, a donor white blood cell infusion within 3 months, a chemotherapy drug called bendamustine within 6 months, any other experimental treatment within 30 days or 5 half-lives (whichever is shorter), high-dose steroid medication within 7 days, certain immune-suppressing drugs within 4 weeks (unless used to treat the cancer itself), or certain oral chemotherapy drugs within a specified period — though an exception exists for BTK inhibitors such as ibrutinib in people with mantle cell lymphoma (confirm with trial site)
• People who currently have, or have been treated for, another cancer within the past 2 years — except for certain non-invasive skin or cervical conditions that were fully treated with no signs of disease remaining
• People who have a genetic condition affecting bone marrow function, such as Fanconi anaemia, Kostmann syndrome, Shwachman syndrome, or any similar condition
• People who have active hepatitis B or hepatitis C, confirmed by a specific blood test, at the time of screening
• People who have HIV infection at the time of screening
• People who have a known allergy or sensitivity to the drugs fludarabine or cyclophosphamide
• People who have a known allergy to gentamicin or related antibiotics
• People who do not meet the minimum body weight required for the planned treatment dose (confirm with trial site)
• People who are pregnant or currently breastfeeding

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