CuraCell Secures German Approval to Begin Phase 1/2a Clinical Trial for TIL Therapy in Colorectal and Prostate Cancers

STOCKHOLM, SWEDEN-August 13, 2025– CuraCell Holding AB, a Swedish immunotherapy company, has received approval from Germany’s Paul-Ehrlich-Institut (PEI) to initiate a Phase I/IIa clinical trial for its novel tumour-infiltrating lymphocyte (TIL) therapy, CC-38. The trial will focus on patients with metastatic colorectal and prostate cancer and is scheduled to begin in the second half of 2025.

Trial Details and Objectives
The open-label Phase I/IIa trial will enroll up to 16 patients with advanced solid tumors and will be conducted at Krankenhaus Nordwest in Frankfurt. The study’s primary objective is to assess the therapy’s safety and tolerability. Secondary objectives include evaluating preliminary anti-tumor activity, measuring immune responses, and exploring the feasibility of repeated administration.

CuraCell’s CEO, Jonas Båtelson, called the approval a “major milestone” and a testament to the company’s scientific and clinical strategy. He added that the trial is a significant step toward the company’s mission of providing curative treatments for the most challenging solid tumors.

About the Therapy
The investigational therapy, CC-38, is an autologous TIL treatment. TIL therapy works by harnessing a patient’s own immune system to fight cancer. The treatment involves extracting tumor-reactive lymphocytes directly from a patient’s tumor, expanding and activating these cells in a laboratory, and then reintroducing them into the patient’s body. CC-38 is built on CuraCell’s proprietary CytoPLY™ platform, which is designed to enhance the functionality and diversity of these tumor-specific T-cells compared to standard methods.