Sweden-based clinical-stage immunotherapy company CuraCell Holding AB announced on Wednesday that it has received approval from the Paul-Ehrlich-Institut to begin a Phase I/IIa clinical trial of its autologous Tumour-Infiltrating Lymphocyte (TIL) therapy, CC-38, for metastatic colorectal and prostate cancers.

CC-38 is based on CuraCell's proprietary CytoPLY platform, designed to enhance tumour-specific T-cell functionality, diversity, and anti-tumour cytotoxicity. This approach expands tumour-reactive lymphocytes derived directly from patient tumours, aiming to boost immune system effectiveness against advanced solid tumours.

The open-label study will enroll up to 16 patients and will be conducted at Krankenhaus Nordwest in Frankfurt. Primary objectives are safety and tolerability, while secondary measures include anti-tumour activity and immune response assessment.

The trial is scheduled to start in the second half of 2025.