FDA Grants Fast Track Designation to Novel HER2-Targeted CAR-M Therapy in Solid Tumors

The FDA has granted fast track designation to the HER2-targeted chimeric antigen receptor-macrophage, CT-0508, for the treatment of patients with solid tumors.

The FDA has granted fast track designation to the HER2-targeted chimeric antigen receptor-macrophage (CAR-M), CT-0508, for the treatment of patients with solid tumors, announced CARISMA Therapeutics, Inc.1

Early research around CT-0508 used in solid tumor xenograft models showed that a single dose of the drug can lead to significant improvement in overall survival (OS) in addition to demonstrating anti-tumor activity.2

“The FDA’s decision to grant fast track designation to CT-0508 is another important milestone in gene-based cell therapy development,” said Steven Kelly, chief executive officer of CARISMA Therapeutics, in a press release.1 “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.”

A first-in-human study of CT-0508 is currently underway in patients with HER2 overexpressing solid tumors. The study aims to determine the safety and tolerability of the agent in 18 patients, as well as the feasibility of manufacturing CT-0508. The secondary end points being explored in the study included estimated objective response rate per RECIST v1.1 and estimated progression-free survival.3

To be included in the study, patients are required to be diagnoses with HER2-positive recurrent or metastatic solid tumor for which no curation therapies are available, an ECOG performance status of 0 or 1, and adequate bone marrow and organ function. The study excludes patients who have human immunodeficiency virus, hepatitis B or C infection, have a diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy, untreated or symptomatic central nervous system metastases cytology proven carcinomatous meningitis, and those with a left ventricular ejection fraction of less than 50%.

Patients with overexpression HER2-positive solid tumors who meet the study’s inclusion and exclusion criteria are being recruited in California at City of Hope National Medical Center, as well as at UNC Lineberger Comprehensive Cancer Center in North Carolina, and Abramson Cancer Center in Pennsylvania.

With an FDA fast track designation, the development of CT-0508 will be expedited to address an unmet medical need in oncology. CARISMA Therapeutics will have early and frequent communication with the FDA to discuss the development of the agent and CT-0508 will also be eligible for a rolling submission of a marketing application following positive study results.1


1. CARISMA Therapeutics announces U.S. food and drug administration grants fast track designation to ct-0508 for the treatment of patients with solid tumors. News release. September 22, 2021. Accessed September 22, 2021. https://bit.ly/3zx1kz2

2. Klichinsky M, Gabrusiwicz K, Anderson N, et al. Abstract 3242: CT-0508 is an anti-HER2 chimeric antigen receptor (CAR) macrophage with targeted anti-tumor activity that promotes a pro-inflammatory solid tumor microenvironment. Presented at the AACR Annual Meetinsl April 27-28, 2020, Philadelphia, PA.

3. CAR-macrophages for the treatment of HER2 overexpressing solid tumors. Clinicaltrials.gov. Accessed September 22, 2021. https://bit.ly/3AEuzla