Production of GMP-peptide vaccines for the phase I PRO-ACTIVE trial in melanoma evaluating a novel cellular therapy approach

Institution: Heidelberg University Hospital
Applicant: Prof. Dr. Dirk Jäger

Funding line:

Translational Research

Schematic presentation of tumor-directed vaccines (1), VIL (vaccine site infiltrating lymphocyte) generation, characterization and expansion (2), and evaluation of VILs as prospective personalized cellular therapy (3).

To improve treatment success and thus the quality of life and life expectancy of cancer patients, new therapies targeting the individual tumor are needed. Innovative immunotherapeutic strategies, such as personalized vaccines or cell-based therapies represent promising approaches for the targeted treatment of cancer.
PRO-ACTIVE is a phase I trial for patients with advanced cutaneous melanoma. In addition to standard treatment wirh immune checkpoint blockers, recruited patients are treated with a peptide vaccine to enhance the immune response against tumor associated antigens like PRAME and NY-ESO-1. In addition to evaluating the safety, tolerability, and immunogenicity of this novel peptide vaccine concept, the study investigates whether vaccine site infiltrating lymphocytes (VIL) isolated from the vaccination site can be reliably used as source material for adoptive cell therapy (ACT).
The financial support by the ForTra gGmbH provides the resources to produce GMP-complian peptides for the PRO-ACTIVE vaccination trial.

Further information: https://www.nct-heidelberg.de/en/the-nct/core-areas/medical-oncology/research/tumor-immunology.html

Prof. Dr. Dirk Jäger and Joscha Kraske (left to right), main principal investigators of the PRO-ACTIVE trial.

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