2025-08-13
Swedish immunotherapy company CuraCell has received approval to initiate a Phase I/IIa clinical trial of its novel TIL therapy, CC-38.
Swedish biotech company CuraCell has received approval from the Paul-Ehrlich-Institut (PEI) in Germany to initiate a Phase I/IIa clinical trial of its investigational TIL (Tumor-Infiltrating Lymphocyte) therapy, CC-38. The upcoming study targets patients with metastatic colorectal and prostate cancer, with the trial set to begin in the second half of 2025.
The approval marks a significant milestone in the development of cell-based immunotherapies for cold solid tumors, which historically respond poorly to conventional immune treatments.
The investigational therapy, CC-38, is developed using CuraCell’s proprietary CytoPLY™ platform. This platform is designed to boost the cytotoxic potential and diversity of tumor-specific T cells, allowing for broader neoantigen recognition and improved anti-tumor immune responses.
According to CuraCell, the trial (EU-CT-Number: 2025-521227-70-00) will enroll up to 16 patients and be conducted at Krankenhaus Nordwest in Frankfurt. Primary endpoints include safety and tolerability, while secondary objectives aim to assess preliminary anti-tumor activity and immune responses. The study also explores the feasibility of repeated dosing.
This CTA approval underlines the continued momentum within the European ATMP landscape, particularly for cell therapy approaches targeting difficult-to-treat cancers. While many TIL therapies are in early development globally, initiatives such as this highlight growing innovation among clinical-stage biotech firms in Sweden and the EU.
To learn more about CuraCell and its TIL program, you can read the official press release: https://news.cision.com/curacell-holding-ab/r/curacell-receives-cta-approval-for-phase-i-iia-clinical-trial-with-innovative-til-therapy-cc-38,c4216907