Study on the Safety and Efficacy of the New Active Ingredient LY4152199 in Patients with Previously Treated B-Cell Lymphoma

B-cell lymphomas are a type of non-Hodgkin lymphoma. They result from the abnormal growth and proliferation of B-cells, which are a type of white blood cell. These diseases can spread to the lymph nodes, bone marrow, or other organs. The most common forms include diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). DLBCL usually grows rapidly (high-grade), while FL grows more slowly (low-grade). Initial treatment generally involves chemotherapy combined with antibodies. In the event of a relapse or lack of response (refractory), further treatments are necessary.

The goal of this Phase 1 study is to evaluate the investigational drug LY4152199 in terms of safety, tolerability, and efficacy. It is a so-called bispecific antibody that binds to two targets simultaneously. One end binds to the BAFF-R protein on the surface of cancer cells, while the other end binds to T cells of the immune system. By binding to the T cells, the body’s own immune system is intended to be activated to specifically attack and destroy the marked cancer cells. Since this is the first study of this drug in humans (first-in-human), the focus is on determining the appropriate dose and assessing safety. The study consists of two parts, beginning with the so-called dose escalation phase. In this phase, small groups of patients receive progressively higher doses of the drug to determine the maximum tolerated dose. During the subsequent dose optimization phase, this dose is then further tested in larger groups of patients to confirm the optimal dose for treatment. LY4152199 is administered as an intravenous infusion. Patients are closely monitored to detect side effects (e.g., immune system reactions) at an early stage. Treatment continues as long as the cancer does not progress and no serious side effects occur. The primary endpoint of the study is to evaluate the safety and tolerability of LY4152199 in order to determine the maximum tolerated and recommended dose.

Eligible participants are adults aged 18 and older with confirmed B-cell lymphoma who have already received at least two standard therapies and no longer respond to them. Important requirements include adequate function of organs such as the liver, kidneys, and bone marrow, as well as good overall health. Patients with central nervous system involvement or severe active infections are excluded from participation. People with autoimmune diseases or severe cardiovascular diseases, as well as those who have undergone an autologous stem cell transplant (within 100 days), are also ineligible to participate.