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 Mantle Cell Lymphoma (MCL) confirmed by a tissue sample, and whose cancer shows a specific protein overproduction (cyclin D1) or a particular genetic change (t(11;14))
• People whose MCL is considered high risk, based on either a scoring system called MIPI-c (at high-intermediate or high risk) combined with certain cell growth rates, and/or a gene or protein change involving TP53
• People who have never received any treatment for MCL before
• People whose cancer is at stage II, III, or IV
• People aged between 18 and 75 years old
• People who have at least one area of cancer large enough to be measured on scans (confirm with trial site for exact size requirements), or if cancer is only in the bone marrow, a bone marrow sample is required
• People who are generally well enough to carry out basic daily activities (based on a standard health performance scale)
• People whose blood counts and organ function test results meet the required levels at the start of the study (unless any abnormalities are caused by the MCL itself)
• People who have no signs of the cancer affecting the brain or spinal cord
• People who are able to understand the study and are willing to sign a consent form and attend all required visits
• People who are sexually active and capable of having children must agree to use a highly effective form of contraception combined with a barrier method during the study, continuing for 6 months after the last CAR T cell treatment or 3 months after the last dose of Ibrutinib, whichever is longer
• Women who could become pregnant must have a negative pregnancy test before joining
• People who are willing to avoid driving a motor vehicle for 8 weeks after receiving the CAR T cell treatment
• People who are able to reach the trial site within 2 hours if a medical problem or emergency occurs

Who may not be able to join:

• People who are not able to give their own consent to participate
• People who do not have the legal capacity or ability to understand what taking part in this study means
• People who have had a known allergic reaction to the study drug, similar drugs, or a group of antibiotics called aminoglycosides
• People who are currently taking part in another clinical trial involving an experimental medicine, or who did so within the 30 days before joining (people in a follow-up phase of another trial with no ongoing trial medication may be eligible — confirm with trial site)
• People who have a physical or mental health condition that the treating doctor believes could put them at risk, affect study results, or interfere with participation
• People with a known or ongoing problem with misuse of medications, drugs, or alcohol
• People with serious ongoing health conditions that could interfere with treatment, including significant heart problems, low oxygen levels at rest, significant fluid around the lungs (if not caused by MCL), or severe uncontrolled diabetes
• Women who are pregnant, planning to become pregnant, or currently breastfeeding; also people with a history of, or currently having, another type of cancer — unless it was a skin cancer (non-melanoma), a pre-cancerous condition, or prostate cancer, and the person has been cancer-free for at least 3 years
• People who have an active infection that is not under control or that requires antibiotics or antifungal treatment given through a drip
• People who test positive for active Hepatitis B infection (people with past or hidden Hepatitis B may still be eligible if the virus is undetectable — confirm with trial site)
• People who test positive for Hepatitis C antibodies, unless a further test shows no active virus in the blood
• People with a known HIV infection
• People with a history of, or current, brain or nervous system conditions such as seizures, stroke, dementia, or certain autoimmune conditions affecting the brain
• People with a history of, or currently active, autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus) that has caused organ damage or required ongoing immune-suppressing medication in the last 2 years
• People who have had a blood clot in a vein or in the lungs requiring blood-thinning treatment within the 6 months before joining
• People with a known severe disorder of the immune system present from birth
• People with any other medical condition likely to affect how safely or effectively the treatment can be assessed
• People who have received a live vaccine within 6 weeks before the planned start of treatment
• People whose personal, family, social, or geographic situation makes it unlikely they can follow the study schedule and requirements

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