Study on the Safety of Epcoritamab for Adults with Returning or Hard-to-Treat Large B-Cell and Follicular Lymphoma
Sponsor: Genmab
ClinicalTrials ID:NCT05451810
This clinical trial is testing the safety of a new drug, epcoritamab, for adults with certain types of lymphoma that have returned or are not responding to treatment. The study involves giving the drug in increasing doses to see how well patients tolerate it.
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Program Overview
This study is focused on understanding the safety of a new treatment called epcoritamab for adults with two types of lymphoma: Diffuse Large B-Cell Lymphoma (DLBCL) and Classic Follicular Lymphoma (cFL) that have either returned after treatment or are not responding to current treatments. Epcoritamab is given as an injection under the skin, and the dose is gradually increased to find the best amount that patients can handle. The study will involve about 184 participants across 80 locations in the United States. Participants will have regular check-ups, including medical exams, blood tests, and questionnaires, to monitor the effects of the treatment and any side effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with returning or hard-to-treat Diffuse Large B-Cell Lymphoma (DLBCL) or Classic Follicular Lymphoma (cFL).
- Must have a specific type of cancer cell marker called CD20+.
- Previously treated with at least one anti-lymphoma therapy for DLBCL and two therapies for cFL, including one anti-CD20 therapy.
- Have at least one tumor that can be measured by scans.
- Must be in relatively good health, with a performance status score between 0 and 2.
- Have adequate organ function.
Exclusion Criteria
- Lymphoma that has spread to the brain or spinal cord.
- Uncontrolled HIV infection. Patients with controlled HIV infection for at least one year are allowed.
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