Phase 2 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 aged 18 to 70 years old (inclusive).
• People who have been diagnosed with a type of relapsed or treatment-resistant B cell Non-Hodgkin's lymphoma (a type of blood cancer), confirmed by a tissue biopsy, including types such as: Diffuse large B-cell lymphoma (DLBCL), Primary mediastinal large B-cell lymphoma (PMBCL), Transformed follicular lymphoma (TFL), High-grade B-cell lymphoma with specific genetic changes (MYC and BCL2/BCL6 rearrangements), Follicular lymphoma (FL), Mantle cell lymphoma (MCL) (with specific chromosomal and protein markers confirmed), or Marginal zone lymphoma (MZL, including MALT lymphoma).
• People whose lymphoma has come back after previously responding to treatment, or whose lymphoma did not respond adequately to standard treatment from the start (confirm specific definitions with trial site).
• People whose lymphoma has come back during or after a stem cell transplant using their own cells (autologous), under specific conditions (confirm with trial site).
• People who cannot tolerate standard treatments, at the treating doctor's discretion.
• People who have previously received specific standard treatments before joining: for Mantle cell lymphoma, prior treatment must have included chemotherapy containing anthracycline or bendamustine, an anti-CD20 antibody therapy, and a BTK inhibitor; for other lymphoma types, prior treatment must have included an anti-CD20 antibody and anthracycline-based chemotherapy (unless the tumour has been confirmed as CD20-negative by the treating doctor).
• People with at least one measurable area of disease visible on imaging scans, meeting specific size requirements (confirm with trial site).
• People whose cancer cells test positive for a protein called CD19, detected on a tissue sample.
• People whose side effects from previous treatments have settled down to a mild level (Grade 1 or lower), with some exceptions for blood-related side effects and minor issues like hair loss.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are able to carry out basic daily activities (confirm with trial site).
• People whose blood cell counts meet minimum levels as determined by blood tests (confirm specific values with trial site).
• People whose kidney, liver, heart, lung, and blood clotting functions are all within acceptable ranges as measured by standard tests (confirm specific values with trial site).
• People of any gender who are willing to use contraception from the time of giving consent until 6 months after completing a preparatory chemotherapy treatment.
• Women who could potentially become pregnant must have a negative pregnancy test before joining; women who have had surgical sterilisation or have been through menopause for at least 2 years are not required to do this.
• People who are willing to take part voluntarily and sign a consent form.

Who may not be able to join:

• People whose doctor estimates their expected survival is less than 3 months.
• People with a history of another cancer (other than certain minor skin cancers or early-stage cancers such as cervical, bladder, or breast) unless they have been cancer-free for at least 3 years.
• People who have previously had a stem cell transplant using donor cells (allogeneic), or any organ transplant.
• People who have previously received any treatment that specifically targeted the CD19 protein.
• People who have received certain recent treatments too close to the planned start of the trial, including: chemotherapy or targeted drug tablets within the past 2 weeks; antibody-based therapies within the past 3 weeks; or radiotherapy within the past 6 weeks (with some exceptions — confirm with trial site).
• People who have previously had CAR-T cell therapy or any other treatment involving genetically modified T cells.
• People who have cancer cells detected in the fluid around the brain or spinal cord, or who have a history of lymphoma affecting the brain or central nervous system.
• People with a history of a severe allergic reaction to the preparatory chemotherapy drugs used in this trial, or to any component of the cell therapy being studied.
• People with an active infection that is not under control or that requires intravenous antibiotics or antifungal treatment.
• People with uncontrolled infectious diseases including HIV, active hepatitis B or C, or active Epstein-Barr virus or cytomegalovirus infection.
• People with a history of, or current, neurological conditions affecting the brain or central nervous system, such as seizures, stroke, dementia, or certain autoimmune diseases involving the nervous system.
• People whose lymphoma directly involves the chambers of the heart.
• People who have had a heart attack, heart procedure (such as stenting or angioplasty), unstable chest pain, or another significant heart condition within the past 12 months.
• People who may need urgent cancer treatment within the next 6 weeks due to a serious and immediate cancer complication (confirm with trial site).
• People with a condition where the immune system does not function properly from birth (primary immunodeficiency).
• People with a history of an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused lasting damage to organs, or that required ongoing immune-suppressing treatment within the past 2 years.
• People who have had a significant blood clot in a vein or in the lungs requiring blood-thinning medication within the past 6 months.
• People with any medical condition that could interfere with how well the trial treatment can be assessed for safety or effectiveness.
• People who have had a severe allergic reaction to any medication or agent used in this trial.
• People who have received a vaccine within 6 weeks before the planned start of the preparatory chemotherapy.
• People who, in the treating doctor's judgement, are unlikely to complete all required trial visits, procedures, and follow-up appointments.

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