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 or older who are able to understand and sign a written consent form agreeing to take part in the study.
• People who agree to allow the trial to use stored tumor tissue samples from a previous biopsy (exceptions may be possible with approval from the study lead doctor).
• People whose general health and ability to carry out daily activities meets a minimum level, as measured by standard medical scoring tools (confirm with trial site).
• People who have a type of lymphoma called mantle cell lymphoma (MCL) that has tested positive for a protein called CD19, confirmed by laboratory testing of a biopsy sample — this applies specifically to people who have previously received a treatment targeting CD19.
• People who are currently taking a drug called acalabrutinib, and have been taking it for between 3 and 7 months before the study screening begins, AND who have had at least one prior treatment regimen (not counting steroids alone), AND whose best response to acalabrutinib so far is a complete response with minimal remaining disease, a partial response, or stable disease.
• People whose disease is measurable on a CT scan (a lesion of at least 1.5 cm) or who have evidence of disease in the blood, spleen, skin, digestive tract, or bone marrow.
• People who have no medical reasons preventing them from undergoing a blood cell collection procedure (leukapheresis), or from receiving steroids or a drug called tocilizumab.
• People whose liver function blood test results fall within acceptable ranges (confirm with trial site for specific values).
• People whose blood cell counts — including white blood cells and platelets — are at acceptable levels, without having needed growth factor injections or a blood transfusion in the 7 days before screening (people with cancer in their bone marrow may be exempt from this requirement — confirm with trial site).
• People whose liver enzyme levels (AST and ALT) are within acceptable ranges (confirm with trial site).
• People whose kidneys are working well enough, as measured by a standard calculation (confirm with trial site).
• People whose blood clotting test results are within acceptable ranges (confirm with trial site).
• Women who could potentially become pregnant must have a negative pregnancy test before joining.
• People whose heart's electrical activity, as measured by a heart tracing (ECG), falls within an acceptable range (confirm with trial site).
• People whose heart is pumping blood effectively enough, as measured by a scan (confirm with trial site).
• People whose blood oxygen levels are adequate, either measured directly or through a lung function test (confirm with trial site).
• People of reproductive potential who agree to use highly effective contraception throughout treatment and for 2 months after the final CAR T cell treatment, or 2 days after the final acalabrutinib dose, whichever comes later.

Who may not be able to join:

• People who have had a donor (allogeneic) stem cell transplant within the past 6 months.
• People who have had their own (autologous) stem cell transplant within the past 3 months.
• People whose cancer stopped responding to, or progressed on, any BTK inhibitor treatment (note: people who switched from another BTK inhibitor to acalabrutinib may still be eligible if total time on all BTK inhibitors was between 3 and 7 months — confirm with trial site).
• People known to have gene changes in their cancer that are associated with resistance to BTK inhibitor drugs.
• People currently using systemic (whole-body) steroids regularly, or who regularly take medications that suppress the immune system (inhaled steroids and low-dose replacement steroids are generally allowed — confirm with trial site).
• People who are receiving any other approved cancer treatment apart from acalabrutinib after joining the study (limited exceptions may apply — confirm with trial site).
• People who need to take certain medications that strongly affect how the body processes a class of drugs involving a liver enzyme called CYP3A4 (confirm with trial site for specific drug names).
• People who are unable to stop taking blood-thinning medications such as warfarin or similar drugs at least 7 days before the blood cell collection procedure and remain off them through the end of treatment.
• People with serious heart failure classified as severe by standard medical criteria (people with well-controlled, symptom-free atrial fibrillation may still be eligible — confirm with trial site).
• People with significant heart rhythm problems that are not well controlled with medication.
• People with an active autoimmune disease that requires ongoing immune-suppressing treatment, including certain blood conditions affecting red blood cells or platelets that are not under control.
• People with a suspected or confirmed serious brain infection called progressive multifocal leukoencephalopathy (PML).
• People who have had a major surgical procedure within 28 days before starting the study drug, or who have not fully recovered from a recent surgery.
• People with a known history of inflammation of the optic nerve (optic neuritis) or other immune-related or inflammatory conditions affecting the brain or nervous system.
• People with a known severe allergic reaction to either of the study drugs.
• People with conditions that significantly affect the ability to absorb medications through the digestive system, including certain bowel diseases, bowel blockages, or prior stomach or small intestine surgery (including some types of weight-loss surgery).
• 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 past 6 months.
• People with a history of another cancer, unless it was treated with the intent to cure and either: has shown no signs of returning for at least 3 years, was an early-stage or skin cancer treated successfully, or is an early-stage prostate cancer being monitored without active treatment.
• People who are currently breastfeeding.
• People with active graft-versus-host disease (a complication that can occur after a donor stem cell transplant).
• People who are HIV positive, or who have active hepatitis B or C infection (detailed hepatitis B and C testing requirements apply — confirm with trial site).
• People who have an active cytomegalovirus (CMV) infection detected by a blood test.
• People with any other active significant bacterial, fungal, or viral infection.
• People with any other medical condition that, in the treating doctor's judgement, would make participation unsafe.
• People who, in the opinion of the trial team, may not be able to follow all study procedures and requirements.

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