Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person joining the trial must give documented informed consent (or have a legally authorised representative do so on their behalf)
• People must agree to allow the trial to use stored tumour tissue from a previous biopsy (exceptions may be possible with approval from the study's lead doctor)
• People must be 18 years of age or older
• People must have a performance status score (a measure of general health and ability to carry out daily activities) of 70 or above on the Karnofsky scale (confirm with trial site)
• People must have a life expectancy of at least 16 weeks at the time of joining
• People must have a relapsed or treatment-resistant intermediate or high-grade B cell non-Hodgkin lymphoma (such as diffuse large B-cell lymphoma, mantle cell lymphoma, or transformed NHL) and either be ineligible for, have refused, or have already had a stem cell transplant using their own cells
• People must have no known reasons they cannot safely undergo the blood collection procedure (leukapheresis), the chemotherapy used to prepare the body, steroids, the drug tocilizumab, or smallpox or related vaccines
• People must have tested positive for a past CMV (cytomegalovirus) infection
• People must have liver function test results within acceptable ranges (total bilirubin at or below 2.0 mg/dL, or up to 3.0 mg/dL for those with Gilbert syndrome; liver enzyme levels below 2.5 times the upper limit of normal)
• People must have kidney function within acceptable ranges (certain blood and clearance measurements must meet minimum thresholds) and must not be on dialysis
• People must have blood counts at or above minimum required levels at initial screening, without the use of transfusions or growth factor medications to reach those levels
• People must have adequate heart function, with the heart pumping at least 45% of its capacity, measured within 8 weeks before joining
• People must be able to maintain an oxygen level above 92% without needing supplemental oxygen
• Women who could become pregnant must have a negative pregnancy test before joining
• People of childbearing potential must agree to use effective contraception or abstain from heterosexual activity throughout the study and for at least 6 months after the last treatment

Who may not be able to join:

• People who have had a donor (allogeneic) stem cell transplant and have not fully recovered, or who have active graft-versus-host disease
• People who have received growth factor medications within 14 days before joining
• People who have received platelet transfusions within 7 days before joining
• People currently using systemic (whole-body) steroids or long-term immune-suppressing medications (low-dose inhaled or topical steroids, or very low-dose replacement steroids, may be acceptable — confirm with trial site)
• People with an active autoimmune disease that requires systemic immune-suppressing treatment
• People currently receiving any other experimental treatments, or concurrent chemotherapy, biological therapy, or radiation therapy
• People with known reasons they cannot safely receive the chemotherapy preparation treatment or CAR T-cell therapy, based on standard medical practice at the trial site
• People with a significant or unstable heart rhythm problem that has not been controlled within two weeks of screening
• People with a known history of optic neuritis, seizure disorder, measurable masses in the brain or spinal cord, or other active inflammatory or immune-related conditions affecting the brain or nervous system (people whose central nervous system disease has been fully treated and is in complete remission may still be eligible — confirm with trial site)
• People with a known history of allergic reactions to compounds similar to the study drugs or to the drug cetuximab
• People with known bleeding disorders such as von Willebrand's disease or haemophilia
• People who have had a stroke or bleeding in the brain within the 6 months before screening
• People with a history of another cancer, unless it was treated with curative intent and meets specific conditions (such as certain skin cancers, non-invasive bladder cancer, or other cancers with no known active disease for 3 or more years — confirm with trial site)
• People with a significant uncontrolled medical illness
• People with an active infection currently requiring antibiotic treatment
• People who are HIV positive
• People with active viral hepatitis (such as active hepatitis B or C)
• Women who are pregnant or breastfeeding
• People with any other condition that the treating doctor believes would make participation unsafe
• People who, in the treating doctor's opinion, may not be able to follow all study procedures and requirements

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