The CAR-M treatment approach

Carisma is pioneering the development of a novel type of cell therapy using the patient’s own immune cells to develop targeted therapies that attack cancer.

Our CAR-Macrophage and CAR-Monocyte cell therapies are designed to both directly attack cancer cells, while at the same time, trigger a broader response from the patient’s own immune system, recruiting T cells, NK cells, and dendritic cells to fight the cancer.

See how CAR-Macrophages work in the treatment of cancer.

CAR-Macrophage Technology

Learn more about the CAR-Macrophage therapy process.

CAR-Macrophage Process

What are clinical trials?

A clinical trial is a study used to learn more about a treatment for a disease or condition. People with the condition being studied are enrolled as volunteers. The purpose of a clinical trial is to determine the safety of a treatment and how well it works.

Clinical trials follow strict guidelines laid out by federal regulatory agencies, such as the U.S. Food and Drug Administration. For more information, visit the U.S. Food and Drug Administration’s website.

Current clinical trials

Enrollment for the Phase 1 clinical trial of CT-0525, a HER2-targeting CAR-Monocyte, has begun.

In March 2024, Carisma made the decision to cease development of CT-0508, a HER2-targeting CAR-Macrophage, given its prioritization of CT-0525 as its lead HER2 product candidate.

Although Carisma plans to continue ongoing activities under its open label Phase 1 clinical trial of CT-0508, enrollment of new patients will be suspended in line with the clinical judgment of the clinical site principal investigator. All patients currently enrolled or in screening will continue participation per protocol through the end of study milestone and will complete all required activities.

Expanded Access Policy

Carisma is focused on developing innovative approaches that have the potential to create life-changing cellular therapies for patients with cancer and other serious disorders. Toward that end, we conduct clinical trials to assess the safety and effectiveness of investigational medicines and we encourage awareness of and participation in clinical trials.

In some cases, when it is not possible for a patient to participate in a clinical trial, the patient’s physician may seek access to a Carisma investigational medicine outside of the clinical trial setting. These situations are often referred to as managed access, expanded access, early access, preapproval access, compassionate use or emergency use.

When necessary, and at the appropriate stage of development, Carisma will consider providing an investigational drug outside of a clinical trial. This will take effect after clinical data is available, for patients who have the serious or life-threatening diseases for which Carisma is developing its investigational product(s), who have exhausted all available therapies and are unable to participate in clinical trials. At such time, Carisma intends to provide additional criteria for which expanded access requests would be evaluated. At our current early stage of drug development and clinical trials, Carisma does not have sufficient clinical data or sufficient evidence of clinical safety and efficacy of our investigational drugs to support expanded access.