CuraCell Announces First Patient Included in Phase I/IIa Clinical Trial of Innovative TIL Therapy CC-38
Stockholm, Sweden – CuraCell TX AB (CuraCell) today announced that the first patient has been successfully included into its ongoing Phase I/IIa clinical trial evaluating the company’s novel autologous Tumor-Infiltrating Lymphocyte (TIL) therapy, CC-38, for patients with metastatic colorectal and metastatic prostate cancer.
This milestone marks the formal launch of clinical testing for CuraCell’s proprietary TIL therapy, developed using its CytoPLY™ platform. CytoPLY™ enhances the activation and enrichment of tumor-reactive lymphocytes, aiming to generate potent and diverse anti-tumor immune responses.
The open-label, single-arm Phase I/IIa study (EU-CT-Number: 2025-521227-70-00) is being conducted at Krankenhaus Nordwest in Frankfurt, Germany. Up to 16 patients with Stage IV colorectal and prostate cancer will be enrolled. The primary objective of the study is to assess safety and tolerability, with secondary endpoints including preliminary efficacy, immune profiling, and feasibility of repeated administration.
“Including the first patient is a pivotal step in translating CuraCell’s TIL platform from scientific innovation to clinical impact,” said Torbjörn Ström, Clinical Operations Manager at CuraCell. “We are pleased to see the trial now actively enrolling and look forward to working closely with our clinical partners to deliver high-quality execution and meaningful outcomes for patients.”
How the treatment works
CuraCell’s autologous cell therapy involves isolating TILs directly from a patient’s tumor, followed by ex vivo activation and expansion using the CytoPLY™ platform. This process enhances the functionality, diversity, and persistence of tumor-reactive T cells. The expanded cells are then reinfused into the patient, where they are designed to recognize and eliminate cancer cells more effectively. “This first-patient milestone reflects the dedication and collaboration of the CuraCell team and our investigators,” said Jonas Båtelson, Co-Founder & CEO of CuraCell. “It’s an important step towards our mission to develop next-generation T- cell therapies capable of delivering durable benefit for patients with cold solid tumors.”
For more information, please contact:
Jonas Båtelson, CEO
Phone: +46 (0)725 527232
Email: jonas.batelson@curacell.se
About CytoPLY™
CytoPLY™ is an advanced T-cell activation and enrichment platform that boosts anti-tumor cytotoxicity by enhancing tumor-specific T-cell functionality and diversity.
CuraCell’s CytoPLY™ platform represents a significant advancement in T-cell immunotherapy by enabling faster and more potent expansion of tumor-killing T cells than traditional IL-2 methods, broadening the TCR repertoire for greater neoantigen recognition, and enhancing cytokine production and T-cell persistence for stronger, longer-lasting anti-tumor responses.
About CuraCell
CuraCell is a clinical-stage European immunotherapy company pioneering advancements in the treatment of cold solid tumors. Its proprietary engineered T-cell reprogramming and expansion process, CytoPLY™, converts dysfunctional tumor-specific lymphocytes into potent cytotoxic effectors while enabling robust expansion from cold solid tumors and preserving stem-like persistence for durable anti-tumor activity. By progressing the development of its lead candidate CC-38, CuraCell is committed to make next-generation T-cell therapies more effective and accessible to patients.
CuraCell’s R&D facility and headquarters are located at Campus Karolinska in Solna, Sweden, with clinical operations in Frankfurt, Germany. To learn more, visit www.curacell.se and follow CuraCell on LinkedIn .
