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:

• People who have been diagnosed with a specific type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL, not otherwise specified), confirmed by a tissue sample test.
• People whose lymphoma has come back after being in remission for 6 months or more, or whose lymphoma did not respond to treatment or came back within 6 months of finishing their last treatment.
• People who have received at least one previous treatment for their lymphoma.
• People who have only had one previous treatment and whose doctors have determined they are not suitable for high-dose chemotherapy followed by a stem cell transplant using their own cells.
• People who have at least one measurable area of lymphoma visible on a CT scan (a lymph node larger than 1.5 cm, or a lesion outside the lymph nodes larger than 1 cm).
• People whose general health and ability to carry out daily activities falls within a certain range, as assessed by a standard medical scale (ECOG score of 0, 1, or 2 — meaning fully active to capable of light activity).

Who may not be able to join:

• People who previously took part in a related clinical trial called STARGLO (Study GO41944).
• People who have only had one prior treatment and whose doctors consider them suitable for a stem cell transplant.
• People whose lymphoma developed by transforming from a slower-growing (indolent) type of lymphoma.
• People diagnosed with certain aggressive forms of B-cell lymphoma involving specific gene changes (MYC and BCL2 and/or BCL6 rearrangements), as classified under 2016 WHO guidelines.
• People with a type of lymphoma called Primary Mediastinal B-Cell Lymphoma.
• People with a history of serious allergic reactions to certain types of antibody-based treatments, or known sensitivity to mouse-derived products.
• People who have previously been treated with glofitamab or similar treatments that target both CD20 and CD3 proteins.
• People who have previously been treated with the chemotherapy drugs gemcitabine or oxaliplatin.
• People with nerve damage or abnormal sensations (such as tingling or numbness) rated as moderate or severe at the time of enrolment.
• People who have received chemotherapy, radiation, immunotherapy, or any experimental cancer treatment within 2 weeks before the first study treatment.
• People who have received antibody-based cancer treatments within 4 weeks before the first study treatment.
• People who currently have, or have a history of, lymphoma affecting the brain or spinal cord — though people whose prior brain/spinal cord involvement has been fully treated and confirmed as resolved by MRI or spinal fluid testing may be considered (confirm with trial site).
• People with a current or past history of certain brain or nervous system conditions, such as stroke, epilepsy, blood vessel inflammation in the brain, or degenerative neurological diseases.
• People with a history of another separate cancer, with some exceptions defined by the trial protocol (confirm with trial site).
• People with serious heart or lung disease.
• People with a known active infection of any kind (bacterial, viral, fungal, or other) at the time of enrolment, or who have had a major infection within 4 weeks before the first study treatment.
• People who have had a confirmed COVID-19 infection within 6 months before the first study treatment, or who test positive for COVID-19 within 7 days before enrolment.
• People with suspected or inactive (latent) tuberculosis.
• People who test positive for Hepatitis B or Hepatitis C.
• People with a known or suspected ongoing Epstein-Barr virus infection.
• People with a known or suspected history of a serious immune condition called Hemophagocytic Lymphohistiocytosis (HLH).
• People with a known history of a serious brain condition called Progressive Multifocal Leukoencephalopathy (PML).
• People who have previously received a transplanted organ from another person.
• People who have previously received a stem cell transplant from another person (donor transplant).
• People with an active autoimmune disease that currently requires treatment.
• People who have taken systemic (whole-body) medications to suppress their immune system within 4 weeks before the first study treatment.
• People who are currently taking ongoing steroid medications in a way that, in the treating doctor's opinion, increases the risk of a serious hormonal side effect called adrenal insufficiency.
• People who have had major surgery within 4 weeks before the first study treatment (not including surgery done only for diagnosis).
• People with a clinically significant history of scarring liver disease (cirrhosis).

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