The Vall d’Hebron Institute of Oncology (VHIO) hosted the 3rd PragmaTIL Annual Meeting on March 26–27 in Barcelona, bringing together consortium partners to review the project’s progress, align on priorities, and define the next steps of the study.
Over two days, participants shared updates across work packages, assessed clinical trial advancements, and discussed recruitment forecasts and operational developments. The meeting also provided a valuable forum to strengthen collaboration among partner institutions and reinforce coordination across the consortium.
Meeting Highlights
The meeting opened with a welcome address by Dr. Elena Garralda, PragmaTIL Coordinator and Director of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM)-CaixaResearch. She outlined the meeting objectives and highlighted key milestones achieved since the previous annual meeting.
An overview of the clinical trial status followed, including updates on site activation and patient recruitment projections. Consortium partners then presented progress across key areas of the project, including investigational medicinal product dossier (IMPD) coordination, regulatory affairs, pharmacovigilance, health economics, sustainability, and overall project management.
Patient-centered aspects were a central focus of the discussions. Dr. Pedro Marchiori-Cacilhas and Dr. Maria Alice Franzoi (Gustave Roussy) led sessions on harmonizing clinical trial implementation, addressing operational challenges, and integrating Patient-Reported Outcomes (PROs). The consortium also reviewed initiatives to enhance supportive care resources and further strengthen patient engagement throughout the study.
A keynote lecture by Prof. Dr. John Haanen (Netherlands Cancer Institute) was a highlight of the meeting. His presentation on redefining tumor-infiltrating lymphocyte (TIL) therapy for melanoma and other cancers sparked insightful discussions on emerging approaches and future directions in the field.
Additionally, Prof. Heinz Philipp Laeubli (University of Basel) shared updates on the BaseTIL-03M trial (NCT05869539), a Phase I study evaluating a novel adoptive cell therapy approach for patients with advanced, treatment-refractory melanoma.
Clinical Trial Update
To date, eight melanoma patients have been treated out of a planned cohort of 40, with recruitment ongoing. Patient enrollment is currently active at VHIO (Spain) and Herlev Hospital (Denmark). The Netherlands Cancer Institute (NKI) has obtained regulatory approval and is expected to begin recruitment shortly, supporting further acceleration toward the enrollment target. Karolinska Institutet and Sheba Medical Center are currently progressing through protocol validation and regulatory approval processes.
To learn more about the PragmaTIL trial, please visit www.pragmatil.eu
PragmaTIL has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement Nº 101104684.
