FDA has cleared an investigational new drug application for CT-0508, an anti-human epidermal growth factor receptor 2-targeted chimeric antigen receptor macrophage.
CT-0508 is sponsored by Carisma Therapeutics Inc.
Under this IND, Carisma intends to initiate its phase I, first-in-human, multi-center study in patients with recurrent or metastatic HER2 overexpressing solid tumors after failure of approved HER2 targeted agents.
“This will be the first time that an engineered macrophage has progressed successfully to the in-patient study phase and represents a new chapter for Carisma: advancing from a preclinical discovery-stage company to a clinical development stage company,” Steven Kelly, president and chief executive officer, said in a statement.
Historically, cell therapies have encountered key challenges treating solid tumors, including limited trafficking to the tumor site, an immunosuppressive tumor microenvironment, and the heterogeneous expression of tumor-associated antigens, but Carisma’s preclinical findings suggest that CAR-M therapy could overcome these challenges.
“Our preclinical findings indicate that CAR-M have the ability to mount a broad immune response against cancers, and the acceptance of the CT-0508 IND brings this technology to patients with incurable solid tumors,” Michael Klichinsky, co-inventor of the CAR-M technology, scientific co-founder, and vice president of discovery at Carisma Therapeutics.
The planned clinical trial will be conducted at two trial sites—University of Pennsylvania in and University of North Carolina—and will enroll patients with different types of recurrent or metastatic cancers with HER2 overexpressing solid tumors.
“HER2 is overexpressed not only in breast and gastroesophageal cancers, but in a wide variety of epithelial origin solid tumors, such as non-small cell lung, colorectal, bladder, and pancreatic cancers,” Debora Barton, chief medical officer at Carisma Therapeutics, said in a statement.
