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:

• A patient or their legal guardian has agreed to take part and has signed a consent form showing they understand the study's purpose and process
• The person is 18 years of age or older (any gender)
• The person has a confirmed laboratory diagnosis of a specific type of B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (several subtypes), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, lymphoma that has transformed from another type, or grade 3b follicular lymphoma
• The person has previously received standard treatments (including a CD20-targeting antibody and a chemotherapy drug called an anthracycline, unless medically not suitable), and their lymphoma has either returned after treatment or has not responded adequately to treatment
• Laboratory tests show that the lymphoma cells carry a protein called CD19 on their surface
• The person has an ECOG performance score of 0 or 1, meaning they are fully active or able to carry out light work (confirm with trial site)
• The person is expected to live for at least 12 weeks
• There is at least one measurable area of disease that can be tracked during the study, based on standard imaging guidelines
• The heart is functioning well enough, with an ejection fraction of 50% or above on an echocardiogram
• Kidney function is within an acceptable range, based on blood test results
• Liver enzyme levels (ALT and AST) are within an acceptable range (a higher limit applies if the lymphoma has spread to the liver)
• Bilirubin levels in the blood are within an acceptable range (a higher limit applies for people with a condition called Gilbert syndrome)
• Blood oxygen levels are 92% or above without the use of supplemental oxygen
• Blood cell counts (white cells, platelets, and haemoglobin) meet minimum levels set by the trial (different thresholds apply if the bone marrow is involved)
• The person does not have a serious mental health condition
• Suitable vein access can be established to allow for a cell collection procedure
• Women who could become pregnant must have a negative pregnancy test, and all participants must agree to use reliable contraception from the time of signing the consent form until one year after receiving the trial treatment — this excludes natural rhythm-based methods and includes options such as hormonal contraception, intrauterine devices, vasectomy, or abstinence; male participants who could father a child must agree to use barrier contraception
• All participants must agree not to donate eggs or sperm for assisted reproduction within one year after receiving the trial treatment

Who may not be able to join:

• People with lymphoma that has actively spread to the brain or spinal cord, or who have primary central nervous system lymphoma (secondary involvement that is not currently active may be considered — confirm with trial site)
• People who have previously received CAR-T cell therapy or any other gene-modified cell therapy
• People who have previously received a bone marrow or stem cell transplant from a donor (allogeneic transplant)
• People who have received chemotherapy, targeted drug therapy, or radiation therapy within a certain period before the cell infusion (specific timeframes apply — confirm with trial site)
• People who test positive for hepatitis B (with detectable virus in the blood), hepatitis C (with detectable virus in the blood), HIV, syphilis, or cytomegalovirus (CMV)
• People with certain serious heart conditions, including severe heart failure (NYHA Class III or IV), a heart attack or heart bypass surgery within the past 6 months, a history of significant irregular heart rhythms or unexplained fainting, or a history of severe non-ischaemic cardiomyopathy
• People who have an active or uncontrolled infection requiring ongoing treatment within one week before screening
• People who have had a moderate to severe immune reaction known as graft-versus-host disease (GVHD) within the 4 weeks before screening
• People who have had a stroke or seizure within the 6 months before screening
• People who have had a blood clot in a deep vein or artery within the 6 months before screening
• People whose blood pressure is not well controlled at the time of screening (defined as 160/100 mmHg or above), although the trial site may allow rescreening if blood pressure is brought under control with medication
• People with a known active or uncontrolled autoimmune disease (such as Crohn's disease, rheumatoid arthritis, lupus, or systemic vasculitis), except for skin conditions that do not need systemic treatment
• People with interstitial lung disease that requires treatment
• People with another active cancer, unless it has been fully treated more than 2 years ago with no active disease remaining, or it is a specific limited cancer type such as cervical carcinoma in situ, certain skin cancers, localised prostate cancer, or ductal carcinoma in situ — all treated with curative intent
• People who have received a live attenuated vaccine within 4 weeks before screening
• People who have taken part in another interventional clinical trial within 4 weeks or 5 half-lives (whichever is longer) before screening
• Women who are pregnant or breastfeeding, or anyone (male or female) who plans to start a family within one year of receiving the trial treatment
• People whom the trial investigators consider unsuitable for the study for any other reason

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