Carisma Therapeutics is Developing CT-0508 to Target HER2 Positive Cancers

Carisma Therapeutics, the manufacturer of CT-0508, issued a press release stating that researchers are conducting a combination study using CAR-M cell therapy plus Keytruda (pembrolizumab) in the treatment of overexpressing solid tumors.

According to Carisma co-founder Michael Klichinsky, in his statement to Cure Today, dosing has begun, with the first patient receiving CT-0508. The Phase 1 study is designed to analyze the tolerance and safety of CT-0508.

Klichinsky is also the company’s CSO. He stated that earlier monotherapy studies of CT-0508 validated the CAR-M mode of action, and the next step is to study its synergism with Keytruda.

About CAR-M

CT-0508 is defined as a human epidermal growth factor receptor 2 (HER2) targeted CAR-Macrophage. In 2021, the FDA granted fast track designation to HER2-directed CAR macrophage (CAR-M) CT-0508 for use as a possible therapeutic option.

Prior studies of CAR-M therapies highlighted its ability to penetrate the tumor and kill cancer cells. CAR-M is a therapy that extracts blood, specifically monocytes, from the patient.

The monocytes are engineered and reinfused into the patient. Notably, cytokine-related side effects have occurred after the procedure, involving the rapid release of cytokines (substances of the immune system). The symptoms that have been reported include, but are not limited to, high fever, chills, headaches, joint pain, and breathing difficulties.

The study is also focused on:

  • Progression-free survival, or the period between the first treatment administration and the date of death; and
  • Objective response rate, or the number of patients that see a response to treatment, whether complete or partial.

CAR-M vs. CAR T-Cell Therapy

Kim A. Reiss M.D., the principal investigator, explained that his team at Pennsylvania State University found that tumor cells cannot process T-cell activation independently, whereas macrophages penetrate the tumors, thereby inducing a reaction.