The US Food and Drug Administration (FDA) has granted Fast Track designation for ’ CT-0525 for the treatment of solid tumours overexpressing human epidermal growth factor receptor 2 (HER2). An ex vivo gene-modified autologous chimeric antigen receptor-monocyte cellular therapy, CT-0525 is being analysed in a Phase I clinical trial. The gold standard of business intelligence.
The open-label trial is designed to assess the safety, tolerability, and manufacturing feasibility of the therapy. Participants enrolled in the trial will include those with locally advanced (unresectable) or metastatic solid tumours that overexpress HER2 and have advanced following treatment with standard therapies approved presently. The trial will also feature two dose escalation cohorts to determine the optimal dose of CT-0525.
With the receipt of FDA Fast Track status, CT-0525 is now poised for an accelerated review process. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form Carisma Therapeutics CMO Eugene Kennedy said: “Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA’s recognition of t.
