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 relapsed or treatment-resistant B-cell non-Hodgkin lymphoma (a type of blood cancer), confirmed by a tissue biopsy, including specific subtypes such as diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, high-grade B-cell lymphoma with certain gene changes, follicular lymphoma, mantle cell lymphoma, or marginal zone lymphoma
• People whose cancer came back after previously responding to treatment, or whose cancer did not respond adequately to standard treatment (specific definitions of "relapsed" and "refractory" apply — confirm details with trial site)
• People who have already received certain standard treatments before joining: for mantle cell lymphoma, this includes a specific combination of chemotherapy, an anti-CD20 antibody therapy, and a BTK inhibitor; for other lymphoma types, this includes anti-CD20 antibody therapy and a chemotherapy regimen containing a drug called anthracycline
• People whose cancer shows at least one measurable tumour lesion of a minimum size, as defined by standard imaging guidelines
• People whose cancer cells test positive for a protein called CD19 (detected by a lab test on a tissue sample)
• People who have recovered from most side effects of previous treatments, with only mild or no ongoing effects
• People who are reasonably well and able to carry out daily activities, as rated on a standard medical scale (ECOG score of 0, 1, or 2)
• People whose blood counts, kidney, liver, heart, lung, and clotting function all meet the minimum levels required by the trial (specific blood test values apply — confirm with trial site)
• People of any gender who are willing to use effective contraception from the time of consent until at least 6 months after completing the preparatory chemotherapy; women who could become pregnant must have a negative pregnancy test before joining (women who have had surgical sterilisation or have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
• People who are willing to take part voluntarily and sign an informed consent form

Who may not be able to join:

• People whose expected survival is less than 3 months, in the opinion of the lead doctor
• People with a history of another cancer (other than certain skin cancers or early-stage cancers such as those of the cervix, bladder, or breast) unless they have been cancer-free for at least 3 years
• People who have had an autologous stem cell transplant (using their own cells) within 3 months before the planned treatment infusion
• People who have ever had an allogeneic stem cell transplant (using another person's cells)
• People who received any cell-based immune therapy within the 3 months before enrolment
• People who have received certain recent treatments within specified timeframes before starting the preparatory chemotherapy: chemotherapy or certain targeted drugs within 2 weeks, antibody-based therapies within 3 weeks, or radiotherapy within 6 weeks (some exceptions may apply — confirm with trial site)
• People who have cancer cells detected in their spinal fluid, brain metastases, or a history of lymphoma affecting the central nervous system
• People whose immune system has developed specific antibodies against the trial treatment (ATHENA-2 CAR-T) that could interfere with it
• People with a history of a severe allergic reaction to the preparatory chemotherapy drugs or any component of the trial treatment
• People with an active infection that is not under control or that requires intravenous antibiotics or antifungal treatment
• People with active or uncontrolled infectious diseases including HIV, active hepatitis B or C, Epstein-Barr virus, or cytomegalovirus infection
• People with a history or current condition affecting the brain or nervous system, such as seizures, stroke, dementia, or certain autoimmune conditions involving the nervous system
• People whose lymphoma has spread into the chambers of the heart
• People who have had a heart attack, heart surgery, stenting, unstable chest pain, or another significant heart condition within the past 12 months
• People who may need urgent cancer treatment within 6 weeks due to a rapidly worsening cancer-related emergency
• People with a primary immune deficiency condition
• People with a history of an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused organ damage or required immune-suppressing medication within the past 2 years
• People who have had a serious blood clot in a vein or lung requiring blood-thinning medication within the past 6 months
• People with any other medical condition likely to interfere with how the treatment works or how safety is assessed
• People who have received a vaccine within 6 weeks before the planned start of the preparatory chemotherapy
• People who, in the investigator's judgement, are unlikely to complete all required visits, procedures, or follow-up requirements of the trial

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