Carisma Therapeutics Announces FDA Clearance of IND for CT-0525, a Novel HER2-Targeting CAR-Monocyte Therapy for Solid Tumors

Recently, Carisma Therapeutics announced that its investigational CAR-monocyte (CAR-Monocyte) CT-0525 has received FDA IND approval in the United States. Clinical research targeting HER2-positive solid tumors will be initiated in the coming months, with the first patient expected to be dosed in the first half of 2024.

CT-0525 is a HER2-targeted CAR-monocyte, and monocytes are precursor cells of macrophages. CT-0525 exhibits the in vivo persistence of CAR-Monocytes and can differentiate into pro-inflammatory CAR-macrophages, possessing a multimodal anti-tumor mechanism of action. It has the potential to overcome cell therapy barriers in solid tumors such as tumor infiltration, immunosuppression in the tumor microenvironment, and antigen heterogeneity.

Preclinical data presented at the Society for Immunotherapy of Cancer annual meeting in November 2022 showed that CT-0525 treatment reduced tumor growth across multiple preclinical solid tumor models.

Moreover, according to reports, Carisma Therapeutics' CAR-Monocyte production platform can produce up to 1 billion cells in a single apheresis session and features a rapid one-day manufacturing process—significantly reducing production time and costs.

Carisma Therapeutics, Inc. focuses on developing engineered macrophages and monocytes to overcome the challenges of solid tumor treatment. As a leader in engineered macrophage therapy, Carisma has advanced two CAR-macrophage therapies into clinical studies—although no further clinical data has been disclosed since the last update in July 2022, which reported good safety.

In addition, Carisma Therapeutics has reached a collaboration with Moderna to jointly discover, develop, and commercialize in vivo CAR-M therapies for cancer treatment.