Carisma Says FDA Grants Fast Track Designation For CT-0525 In HER2-Overexpressing Solid Tumors

(RTTNews) - Biopharmaceutical company Carisma Therapeutics, Inc. (CARM) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).

The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525.

This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The initial study design will consist of two dose escalation cohorts.

Carisma said it is looking to work closely with the FDA to accelerate the development of CT-0525. It is currently enrolling patients in the Phase 1 clinical trial and remains on track to report initial clinical data by the end of 2024.