FDA grants fast track designation to CAR macrophage cell therapy for HER2-positive tumors
The FDA granted fast track designation to CT-0508 for treatment of patients with solid tumors that overexpress human epidermal growth factor receptor 2.
CT-0508 (Carisma Therapeutics) is an autologous, gene-edited chimeric antigen receptor macrophage therapy that targets the HER2 protein on the surface of solid tumor cells.
Carisma Therapeutics’ technology — developed as part of a collaboration with University of Pennsylvania — capitalizes on previous cell therapies by using genetically engineered macrophages that are naturally drawn into solid tissues and help modulate the tumor microenvironment.
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
“The FDA's decision to grant fast track designation to CT-0508 is another important milestone in gene-based cell therapy development," Steven Kelly, CEO of CARISMA, said in a company-issued press release. “This designation further demonstrates the critical need to expedite the development and review of new therapies that can potentially address the unmet needs of patients whose cancer may have not responded to existing methods of treatment.”
Enrollment is underway for a first-in-human, multicenter clinical trial of CT-0508. The trial will include patients with recurrent or metastatic HER2 overexpressing solid tumors who previously received HER2-targeted agents, as well as patients whose disease does not have an approved HER2-targeting agent.
Study sites for the phase 1 trial include Abramson Cancer Center of University of Pennsylvania, City of Hope and University of North Carolina Lineberger Comprehensive Cancer Center.