On August 13, 2025 CuraCell reported that the Paul-Ehrlich-Institut (PEI), the German federal authority for vaccines and biomedicines, has approved the company’s Clinical Trial Application (CTA) to initiate a Phase I/IIa clinical trial evaluating its novel autologous TIL (Tumor-Infiltrating Lymphocyte) therapy, CC-38, in patients with metastatic colorectal cancer and metastatic prostate cancer. The clinical trial is planned to commence in the second half of 2025.

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The open-label Phase I/IIa trial will enroll up to 16 patients with advanced solid tumors, including colorectal and prostate cancer (EU-CT-Number: 2025-521227-70-00). The study will be conducted at Krankenhaus Nordwest in Frankfurt. The trial will assess the feasibility of repeated administration, with safety and tolerability as the primary endpoints. Secondary objectives include evaluating preliminary anti-tumor activity and immune responses.

"This CTA approval marks a major milestone for CuraCell and affirms the strength of our science and clinical strategy," said Jonas Båtelson, CEO of CuraCell. "Our dedicated team, together with our expert collaborators, has worked tirelessly to advance our first TIL therapy from bench to bedside. This is a big step forward in our mission to provide curative treatments for the toughest and most deadly solid tumors."

(Press release, CuraCell, AUG 13, 2025, View Source [SID1234661187])