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 who have been diagnosed with certain types of large B-cell lymphoma (specifically DLBCL or closely related subtypes), confirmed by a laboratory test on a tissue sample, as classified by the WHO 2016 system.
• People whose lymphoma has come back or stopped responding to treatment after at least 2 rounds of chemotherapy that included the drugs rituximab and an anthracycline, and who have either already had a stem cell transplant using their own cells (autologous), were not suitable for that transplant, or chose not to have it — with specific definitions of "not responding" or "relapsed" depending on treatment history (confirm with trial site).
• People aged 18 or older.
• People who are generally well enough to carry out normal daily activities, or whose reduced ability to do so is directly caused by the lymphoma itself (this is measured using a standard scale called ECOG — confirm with trial site).
• People who have measurable signs of lymphoma that can be detected on a specific type of scan (PET/CT scan).
• People who have at least 20 tissue slides available from a previous biopsy, or who are willing to have a new biopsy if older tissue is not available.
• People with no current suspicion of lymphoma affecting the brain or spinal cord.
• People who have a history of brain or spinal cord disease, provided there are currently no symptoms, no active disease visible on an MRI scan, and no lymphoma cells found in the fluid around the brain and spinal cord.
• People who have had a stroke in the past, provided it happened more than 12 months before the blood collection procedure (leukapheresis) and any lasting effects are stable.
• People whose kidneys are working well enough, based on a blood test measuring kidney filtering ability (above a certain level — confirm with trial site).
• People whose heart is pumping with at least 45% efficiency, as measured by an ultrasound of the heart (echocardiogram).
• People whose blood oxygen level is above 90% while breathing normal room air.
• People whose liver test results (ALT and AST) are below 5 times the upper limit of normal.
• People whose total bilirubin (a measure of liver function) is below a certain level, with an exception for people with a condition called Gilbert's syndrome.
• People with blood count results above specific minimums for neutrophils (a type of white blood cell), lymphocytes (another type of white blood cell), and platelets (confirm with trial site for exact values).
• People with a life expectancy of more than 3 months, not counting the lymphoma itself.
• People who are able and willing to use effective birth control from the time of joining the trial through the follow-up period, if there is any possibility of becoming pregnant or fathering a child.

Who may not be able to join:

• People whose lymphoma started in the brain or spinal cord (primary CNS lymphoma).
• People whose DLBCL developed from a type of blood cancer called chronic lymphocytic leukaemia (CLL), known as Richter's transformation.
• People who are not able to give informed consent to participate.
• People with a known history of HIV infection, or active hepatitis B, unless specific blood tests confirm the virus is not detectable; people with certain hepatitis B blood markers may still be considered if they receive antiviral medication as recommended (confirm with trial site).
• People with a known history of hepatitis C, unless blood tests confirm the virus is undetectable.
• People who have had active seizures, have ongoing seizure activity, or have been on anti-seizure medication within the past 12 months.
• People who have had a stroke within the past 12 months.
• People with a known history of an autoimmune disease affecting the brain or nervous system, such as multiple sclerosis or optic neuritis.
• People with an active brain or nervous system condition that, in the doctor's judgement, may make it difficult to assess side effects related to the nervous system.
• People with an active systemic infection caused by fungus, a virus, or bacteria.
• People who are pregnant or breastfeeding.
• People with a current or previous other cancer, with certain exceptions for cancers that have been fully treated and in remission for at least 2 years, or certain skin cancers that have healed adequately, or certain cancers being managed with hormonal therapy and in remission for at least 2 years (confirm with trial site for full details).
• People who have had a non-neurological autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that required strong immune-suppressing or disease-modifying treatment within the last 2 years.
• People who require ongoing, long-term use of steroid medications (such as prednisone) at a dose above 10 mg per day.
• People who have had a heart attack, heart procedure (such as angioplasty or stenting), unstable chest pain, or another serious heart condition within the past 6 months.
• People currently receiving radiotherapy (though radiotherapy up to the time of the blood collection procedure may be allowed — confirm with trial site).
• People with existing significant memory or thinking difficulties that would interfere with treatment or monitoring, as assessed by a specific evaluation tool at the start of the trial.
• People with a known history of severe allergic reactions to any of the medications used in this trial.
• People who are not willing to take part in a separate long-term follow-up study related to gene therapy.
• People who have previously received CAR T-cell therapy for any condition.
• People who have previously had a stem cell transplant using cells from another person (allogeneic transplant) for any condition.
• People who have previously received a type of cancer treatment called bispecific antibodies.
• People who have previously received a type of treatment called T-cell receptor-engineered T-cell therapy.
• People who have previously received treatment targeting a protein called CD19 (anti-CD19 immunotherapy).
• People with a known allergy or hypersensitivity to the trial treatment (MB-CART2019.1) or any of its components, including materials derived from cattle or rodents, or to any other medications likely to be given during the trial such as preparative chemotherapy or rescue medications.

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