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 (a type of blood cancer) that has come back after treatment or has not responded to treatment.
• People who have previously received a specific type of immune cell therapy called anti-CD19 CAR T-cell therapy, and whose cancer did not respond to or who could not tolerate a type of drug called a BTK inhibitor.
• People who have at least one measurable area of disease visible on a CT scan (a lymph node lesion of at least 1.5 cm, or a lesion outside the lymph nodes of at least 1 cm).
• People aged 18 or older (children are not included in this trial).
• People who are reasonably well and able to carry out daily activities, as assessed by a standard medical scale (confirm with trial site).
• People whose blood counts and organ function (including white blood cells, platelets, liver, and kidneys) meet certain minimum levels, as measured by blood tests (confirm with trial site).
• People living with HIV, provided the virus is well controlled on treatment and was undetectable within the past 6 months.
• People with a past or current hepatitis B infection may be eligible if the virus is currently undetectable and the surface antigen test is negative, with regular monitoring required throughout the trial.
• People with a past hepatitis C infection may be eligible if the virus is currently undetectable.
• People who have had brain metastases (cancer that has spread to the brain) that have already been treated, provided there is no sign of new growth and there are no current symptoms.
• People with new or growing brain metastases or disease affecting the lining of the brain, if the treating doctor determines no immediate brain-specific treatment is needed during the first treatment cycle.
• People who have or have had another cancer that is unlikely to interfere with this trial (for example, prostate or breast cancer being managed with hormonal therapy).
• People who are able and willing to use effective contraception during the trial and for a specified period after treatment ends (2 months after the end of glofitamab for men and women; 6 months after obinutuzumab for men; and 18 months after obinutuzumab for women).
• People who are able to understand the trial and are willing to sign a consent form (a legal representative may do this on a participant's behalf if needed).

Who may not be able to join:

• People who are still experiencing significant side effects (above a mild level) from a previous cancer treatment, except for hair loss.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have previously had a serious allergic reaction to drugs that are chemically or biologically similar to the trial drugs glofitamab or obinutuzumab.
• People who are pregnant or breastfeeding, as the trial drugs may harm an unborn baby or infant.
• People who are currently experiencing or have recently required treatment for a serious immune reaction called cytokine release syndrome (CRS) within the past 14 days.
• People who are currently experiencing or have recently required treatment for serious nervous system side effects (neurotoxicity) within the past 14 days.
• People who have needed antibiotic, antiviral, or antifungal treatment for an active infection, or have been hospitalised for infection, within the past 14 days — the infection must be fully resolved before starting the trial.
• People who have been taking strong immune-suppressing medications (such as high-dose steroids or certain other drugs) within the past 14 days, though inhaled steroids are permitted (confirm with trial site for the full list).
• People with a known or suspected ongoing infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV).
• People with a known or suspected history of a serious immune condition called hemophagocytic lymphohistiocytosis (HLH).
• People who have previously been treated with glofitamab or similar drugs that target both CD20 and CD3 at the same time.
• People with a known history of a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with a current or past history of certain brain or nervous system conditions such as stroke (within the past 2 years or with lasting effects), epilepsy, brain blood vessel inflammation, or degenerative brain disease.
• People with serious heart problems, including severe heart failure, a heart attack within the past 3 months, unstable heart rhythm, or unstable chest pain.
• People who have had major surgery for non-diagnostic reasons within the past 4 weeks.
• People who have received a live vaccine within the past 4 weeks or who are expected to need one during the trial.
• People who have tested positive for COVID-19 (SARS-CoV-2) within the past 7 days.
• People with a current or past diagnosis of a blood condition called Waldenström macroglobulinemia.
• People with an active autoimmune disease (where the immune system attacks the body) that could be worsened by immunotherapy, unless the condition is well controlled or only a distant history.

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