CuraCell granted approval for trial of new therapy for metastatic cancers

Ella Day | August 13, 2025 | News story | Research and Development |  CuraCell, Immunology, clinical trial, immunotherapy, metastic cancer 

Swedish immunotherapy company, CuraCell, has received approval from the Paul-Ehrlich-Institut in Germany to begin a phase 1/2a clinical trial of its tumour-infiltrating lymphocyte (TIL) therapy, CC-38, for patients with metastatic colorectal and prostate cancer.

The trial, scheduled to start later this year in Frankfurt, Germany, will recruit up to 16 patients with advanced solid tumours. The primary objectives will focus on assessing safety and tolerability of the therapy, while secondary endpoints will evaluate preliminary anti-tumour activity and immune responses. The study will also investigate the possibility of repeated administration.

TIL therapy involves isolating and expanding tumour-reactive lymphocytes from patients’ tumours to enhance the immune system’s capacity to target cancer. CC-38 is based on CuraCell’s CytoPLY platform, which aims to improve tumour-specific T-cell functionality and diversity compared to standard methods.

“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.

CuraCell specialises in developing immunotherapies for hard-to-treat solid tumours, with operations in both Sweden and Germany.

Ella Day

13/8/25