Bispecific T-Cell engager (BiTE) therapy is a novel immunotherapy approach that helps the body’s immune system target cancer cells. Bispecific T-Cell engagers are a form of cancer treatment designed to leverage the two arm-structure of antibodies in order to bind to both malignant (cancer) cells and T-cells in the body.
Antibodies are naturally produced by the body in response to infections, neutralizing the foreign agents by binding to and destroying them in a specific lock and key fashion. Because antibodies have a two-arm structure, they can be modified to attach to two different cell markers at once.
T-cells are part of the immune system and help the body fight infections and cancer. Cancer often hides by becoming invisible to the T-cells. Unmodified or natural antibodies are unable to recruit T-cells to directly fight the cancer, so these lab-developed antibodies provide a workaround to assist in the process.
After being created in the lab, BiTEs are typically infused into the body. One of the major benefits of this type of therapy is that it is available “off-the-shelf”, meaning that it is ready for immediate use and can be given to patients right away as opposed to requiring individual patient manufacturing.
In BiTEs that are designed to treat myeloma, one end of the antibody binds to the myeloma cells and the other binds to the T-cells. Once infused, these BiTEs can grab onto both the myeloma cells and the body’s own immune cells, helping to bring them together and activating them to kill the myeloma cells. One way to think about it is to imagine a person with two hands. The left hand grabs the T cell and the right hand grabs the myeloma cell. The two hands bring the cells together and the T cell gets activated to attack the myeloma.
The process of using cancer cell-based markers and the body’s immune system is a form of precision medicine which can allow targeted myeloma treatments to be delivered directly where they are needed, avoiding areas where they are not.
Watch this animation to learn more about how BiTEs work in myeloma.
FDA Approval and Clinical Trials
In October 2022, the U.S. Food and Drug Administration (FDA) approved the first bispecific t-cell engager (BiTE) for patients with relapsed or refractory multiple myeloma. This drug, known as teclistamab (TECVAYLI), is given via a subcutaneous injection (under the skin) for patients who previously received four or more prior lines of therapy. Teclistamab targets B-cell maturation antigen (BCMA), a protein commonly found on myeloma cells.
In August 2023, the FDA approved two additional BiTE therapies, talquetamab (Talvey) and elranatanab (Elrexfio), for patients with relapsed or refractory multiple myeloma patients who have received at least four prior lines of therapy. These therapies are also given via a subcutaneous injection. Elranatanab targets BCMA, while talquetamab targets the GPRC5D protein and is an alternative treatment option for patients who may not have responded to BCMA-targeted therapies.
In July 2025, the FDA approved linvoseltamab-gcpt (Lynozyfic) for patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. This therapy is given via intravenous (IV) injection and targets BCMA.
Research and additional clinical trials for new BiTE therapies are ongoing in an effort to continue to evaluate other potential alternative treatments for cancer patients. We have a number of these clinical trials open at Weill Cornell Medicine and NewYork-Presbyterian Hospital. Learn more about our open trials here.
While treatment with BiTE therapy is promising, there are certain risks associated with this treatment approach. Typically the side effects are very treatable, but people who receive BiTE therapy will be monitored closely, especially at the start of treatment. Possible side effects include:
Cytokine release syndrome (CRS): Sometimes T cells release chemicals called cytokines that ramp up the immune system. Noticing a high fever, chills, trouble breathing, severe nausea, dizziness, headaches, a fast heartbeat, or extreme fatigue after receiving BiTE therapy, may indicate CRS and should be communicated right away to the care team.
Other side effects: Fever, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea have also been noted in some patients.
CancerCast Podcast
Learn more about BiTE therapy on the Weill Cornell Medicine CancerCast podcast. Dr. Mateo Mejia explains how this therapy works, the benefits for patients, common side effects, and the future of this form of therapy. Listen on Apple Podcasts, Spotify, YouTube or the Weill Cornell Medicine website.