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:

• People who have been diagnosed with an aggressive B cell non-Hodgkin lymphoma (NHL), confirmed by tissue testing — including diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma, follicular or marginal zone lymphoma that has transformed into DLBCL, or high-grade B cell lymphoma (not otherwise specified).
• People whose lymphoma is considered high-risk, based on a blood marker called LDH being above the normal range, measured at or within two weeks of the cell collection procedure (leukapheresis).
• People who have received exactly one prior course of treatment for their large B cell lymphoma (the trial is designed for people moving on to a second-line treatment called Axi-Cel).
• People who have at least one measurable area of disease visible on a PET-CT or CT scan (if the only disease visible is in lymph nodes, at least one node must be 1.5 cm or larger).
• People aged 18 or older.
• People who are generally well enough to carry out light activity, as measured by a standard fitness scale (ECOG score of 0 or 1); a score of 2 may be accepted if the reduced fitness is caused entirely by the lymphoma itself.
• People whose blood counts and organ function meet specific minimum standards, including adequate kidney, liver, heart, and lung function, healthy enough platelet and white blood cell levels, no significant fluid build-up around the heart or lungs, and a resting blood oxygen level above 92% (confirm with trial site for exact values).
• People who are able to understand the study and are willing to sign an approved consent form.
• Women of childbearing potential who have a negative pregnancy test before joining.
• People of childbearing or child-fathering potential who are willing to use reliable birth control from enrolment through to 12 months after receiving the preparatory treatment.
• People who have previously received a CD19-targeted therapy and whose lymphoma still tests positive for the CD19 marker on biopsy.
• People whose most recent systemic treatment finished at least 2 weeks ago, or at least 5 half-lives of that treatment ago — whichever period is shorter — before the planned cell collection procedure.

Who may not be able to join:

• People who have previously been treated with CAR-T cell therapy or any other adoptive cell therapy.
• People who have previously had an allogeneic (donor) stem cell transplant.
• People who require bridging therapy (treatment given between cell collection and the study treatment) other than steroids or radiotherapy; additionally, there must be at least one measurable, non-irradiated area of disease remaining after cell collection.
• People with active lymphoma affecting the central nervous system (brain or spinal cord); people with a prior history of CNS lymphoma involvement must have a brain MRI showing no current CNS disease.
• People with a history of a serious allergic or infusion reaction to Axi-Cel or any of its components.
• People with a history of Richter's transformation originating from chronic lymphocytic leukaemia, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
• People with any other medical condition that, in the investigator's judgement, could interfere with assessing the safety or effectiveness of the study treatment.
• Women who are pregnant or breastfeeding.
• People with a history of another invasive cancer, unless they have been free of that cancer for at least five years — with exceptions for non-melanoma skin cancers, certain in-situ cancers (such as cervix, bladder, or breast), and people in remission for more than one year who are receiving hormonal therapy.
• People who have had a stroke or mini-stroke (transient ischaemic attack) within the 12 months before enrolment, or who have a seizure disorder currently requiring anti-seizure medication.
• People who, in the investigator's judgement, are unlikely to complete all required study visits, procedures, or follow-up appointments.

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