Phase 2 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:

• People who are 18 years of age or older.
• People who have been diagnosed with diffuse large B-cell lymphoma (DLBCL) — including certain subtypes — or follicular lymphoma Grade 3B, confirmed by a specialist tissue review at the participating hospital.
• People whose lymphoma has come back or stopped responding to at least one previous treatment (previous CAR-T therapy or a stem cell transplant using the person's own cells are allowed).
• People whose cancer has measurable areas of disease at least 1.5 cm in size, visible on a CT or PET/CT scan.
• People whose tumour tests positive for both CD19 and CD20 proteins after their most recent treatment.
• People who have recovered from most side effects of previous cancer treatments (hair loss aside) before starting the trial.
• People with a life expectancy of more than 12 months.
• People who are well enough to carry out light daily activities (as rated on a standard medical scale called ECOG, with a score of 2 or lower).
• People who are willing to provide a tumour tissue sample (from a biopsy done as part of standard care) before starting treatment, or who may be granted an exception by the trial's lead doctor if this is not possible.
• People whose blood counts and organ function (liver, kidneys, and blood clotting) fall within acceptable ranges as measured by blood tests (confirm specific values with the trial site).
• People who have signed a consent form, or whose legal representative has done so on their behalf.
• Women who could become pregnant must have a negative pregnancy test before starting and must agree to use two reliable forms of contraception — including at least one with a very low failure rate — starting at least 28 days before treatment, throughout treatment, and for at least 3 months after the last dose of mosunetuzumab or 9 months after the last dose of loncastuximab tesirine, whichever is later. Women must also agree not to donate eggs during this period.
• Men who could father a child must agree to use a condom with any partner who could become pregnant or who is pregnant, throughout treatment and for 3 months after the last dose of mosunetuzumab or 6 months after the last dose of loncastuximab tesirine, whichever is later. Men must also agree not to donate sperm during this period.

Who may not be able to join:

• People who have previously been treated with loncastuximab tesirine (one of the study drugs).
• People who have previously been treated with mosunetuzumab or any other CD20-directed bispecific antibody (a type of targeted therapy).
• People who have had an allogeneic stem cell transplant (a transplant using cells from a donor).
• People who have received a monoclonal antibody, radioimmunotherapy, or antibody-drug conjugate within the 2 weeks before the planned start of the trial.
• People who have received chemotherapy or any other anti-cancer treatment (including experimental treatments) within 2 weeks, or within 5 half-lives of that drug, before the planned start of the trial — whichever period is shorter.
• People who have received radiotherapy within 2 weeks before the planned start of the trial (with some exceptions — confirm with the trial site).
• People who have had a stem cell transplant using their own cells within 30 days before the planned start of the trial.
• People who have received CAR-T cell therapy within 30 days before the planned start of the trial.
• People who have received a live vaccine within 30 days before the planned start of the trial.
• People currently taking part in another experimental treatment study.
• People who experienced significant immune-related side effects from a previous immunotherapy treatment (some exceptions may be possible with the lead doctor's approval).
• People taking high-dose steroid tablets or other immune-suppressing medicines for lymphoma symptoms, unless the dose has been reduced to a low level (some exceptions apply — confirm with the trial site).
• People with a known allergy to medicines made using a particular cell line (Chinese hamster ovary cells), or who have had serious allergic reactions to medicines similar to those used in this trial.
• People with a significant build-up of fluid in the abdomen or around the lungs that is causing symptoms or needs draining.
• People who have had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with a known or suspected history of a serious immune condition called haemophagocytic lymphohistiocytosis (HLH).
• People with a serious uncontrolled illness.
• People with a known active infection (bacterial, viral, fungal, or other) at the time of joining the trial (fungal nail infections are excluded from this).
• People with active hepatitis B or hepatitis C infection (people with past hepatitis B or C who now have undetectable levels of the virus in their blood may still be eligible — confirm with the trial site).
• People with active HIV infection (people with HIV who have an undetectable viral load, a CD4 count above 200, and who are on HIV medication may still be eligible — confirm with the trial site).
• People with a known or suspected chronic active Epstein-Barr virus (EBV) infection.
• People whose lymphoma has spread to the brain or spinal fluid.
• People who have had severe skin reactions (such as blistering or Grade 3 or higher rash) from a previous immunotherapy treatment.
• People who have had a significant heart problem, stroke, or heart attack within the past 6 months.
• People with a clinically significant history of liver disease, including cirrhosis or viral hepatitis.
• People with an autoimmune disease that is currently being treated (some exceptions apply, including well-controlled thyroid conditions, controlled Type 1 diabetes, and certain stable autoimmune conditions — confirm with the trial site).
• People who have had major surgery within 4 weeks before the planned start of the trial (except surgery done to diagnose the cancer).
• People who have had another type of cancer that has not been in remission for at least 2 years (some exceptions apply for certain low-risk cancers — confirm with the trial site).
• Women who are pregnant or breastfeeding.
• People who, in the trial doctor's judgement, have any other condition that would make participation unsafe.
• People who, in the trial doctor's opinion, may not be able to follow all of the trial's requirements.

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