AgenT-797 is an experimental cancer treatment being studied in clinical trials. It belongs to a newer category of treatments called cellular immunotherapy, which uses immune cells to help the body recognize and fight cancer. AgenT-797 is not yet approved by the U.S. Food and Drug Administration (FDA), but early research suggests it may offer a safer and more accessible option compared with some existing cell therapies.
The treatment is being developed by Agenus.
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How Is AgenT-797 Different From Other Cell Therapies?
Some patients may be familiar with CAR T-cell therapy, another type of immune-based treatment. AgenT-797 works in a different and potentially gentler way. Instead of using a patient’s own immune cells that must be collected and genetically changed, AgenT-797 is made from carefully prepared immune cells donated by healthy individuals. This allows the treatment to be available more quickly and avoids long waiting times.
Another important difference is safety. AgenT-797 is designed to activate the immune system in a more balanced way. Early studies suggest it causes fewer severe immune-related side effects than some other cell therapies, which may make it an option for patients who are older, frail, or have already received many treatments.
How Does AgenT-797 Work?
AgenT-797 uses a special immune cell called an invariant natural killer T cell, or iNKT cell. These cells act as coordinators of the immune system. When activated, they send signals that help other immune cells wake up and attack cancer.
Rather than targeting only one specific cancer marker, AgenT-797 helps stimulate a broader immune response. This may be especially helpful in cancers that have learned how to hide from the immune system or stop responding to standard treatments.
Which Cancers Are Being Studied?
So far, AgenT-797 has been studied mainly in blood cancers, particularly in patients whose disease has returned or stopped responding to treatment. These include conditions such as multiple myeloma and acute myeloid leukemia (AML). Many patients in these trials had already tried several other therapies and had limited remaining options.
Researchers are also exploring whether AgenT-797 could be useful in solid tumors in the future, especially when combined with other immunotherapies that help remove immune “brakes.”
What Do Clinical Trials Show So Far?
AgenT-797 has been tested in early-stage clinical trials, including a first-in-human study (ClinicalTrials.gov ID: NCT04754100). These studies focused mainly on safety and on understanding how the immune system responds to treatment.
In these trials, AgenT-797 was generally well tolerated. Some patients showed signs that their immune system became more active after treatment, and in a few cases the cancer slowed down or stabilized for a period of time. Because these were early studies with small numbers of patients, researchers are careful not to draw firm conclusions yet. Larger trials are needed to better understand how effective the treatment may be.
How Is AgenT-797 Given?
AgenT-797 is given through an intravenous (IV) infusion, similar to many chemotherapy or immunotherapy treatments. Unlike some other cell therapies, patients usually do not need chemotherapy beforehand to prepare their immune system. In some trials, the treatment has been given more than once, which is possible because of its favorable safety profile.
Because AgenT-797 is prepared in advance from donor cells, treatment can often begin more quickly than with personalized cell therapies.
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What Side Effects Have Been Seen?
One of the most encouraging aspects of AgenT-797 so far is its safety profile. In early clinical trials, most side effects were mild and temporary. Some patients experienced fatigue, low-grade fever, or infusion-related symptoms shortly after treatment.
Importantly, serious immune reactions such as severe cytokine release syndrome or brain-related side effects, which can occur with other cell therapies, have been uncommon. There have also been no reports of graft-versus-host disease, a serious complication sometimes seen with donor immune cells. Doctors continue to monitor patients closely in all ongoing studies.
What Can Patients Expect Going Forward?
AgenT-797 is still being studied, and it is not yet clear who will benefit the most. Ongoing research aims to identify which patients are most likely to respond and how best to combine this therapy with other treatments. If future trials confirm both safety and effectiveness, AgenT-797 could become an additional option for patients with difficult-to-treat cancers.
Final Thoughts
AgenT-797 represents a new direction in cancer immunotherapy, focusing on activating the immune system in a controlled and coordinated way. For patients with advanced cancers who have limited options, this approach offers cautious hope. Anyone interested in AgenT-797 should speak with their oncology team about whether a clinical trial may be appropriate.
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Written by Armen Gevorgyan, MD