This study will evaluate the antibody therapy odronextamab for patients with relapsed B-cell non-Hodgkin lymphoma (NHL). The primary outcomes will be how many patients respond to treatment, and how many have a complete response (cancer no longer detectable).
The details
For B-cell NHL which has relapsed (returned) after previous treatment, immune therapies are an option. Antibody therapy uses small molecules that attach to the cancer cell and signal to white blood cells to destroy the cancer cell.
Odronextamab (REGN1979) is an antibody therapy. Unlike most antibody therapies, odronextamab can attach to two targets. The CD20 target allows odronextamab to attach to B-cell NHL. By also attaching to the CD3 target, odronextamab aids T-cell white blood cells in activating and killing the NHL.
This phase II troal will evaluate odronextamab as a treatment for relapsed B-cell NHL. The primary outcomes are overall response and complete response.
Who are they looking for?
This study is looking for 481 patients with B-cell NHL. For patients with the NHL subtype of follicular lymphoma, it must be Grade 1 to 3a. For other types of NHL, patients must have received two previous treatments which they did not respond to or relapsed after. Participants must have measurable disease and have adequate bone marrow, liver, and kidney function.
Patients whose cancer has spread to the brain or spinal cord are not eligible. Patients must not have previous treatment with allogeneic stem cell transplant or chimeric antigen receptor T-cell (CAR-T) therapy. Patients also must not have seizures, another cancer besides NHL, HIV infection, or hepatitis B or C.
How will it work
There are 5 sections of this study. Each section will study a specific subtype of B-cell NHL: follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, marginal zone lymphoma, and other. All patients will be treated with odronextamab for 28 weeks, and their response to treatment will be measured.
Overall, participants will be followed up for up to 194 weeks after the first dose.
