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Article History

Received: 22 July 2022

Accepted: 16 December 2022

First Online: 30 December 2022

Declarations

:

: The study protocol, the patient informed consent and all forms of participant information related to the study have been reviewed and approved by the medical research ethics committee (METC) of the Antoni van Leeuwenhoek on February 24, 2022, reference number NL78423.031.21. Any substantial amendments made to the study documents will be submitted and reviewed as a modification and must be approved by the METC before implementation. The protocol was written and the study was conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice (GCP), the Declaration of Helsinki and the Medical Research Involving Human Subjects Act (WMO).Prior to participation, all patients will be informed of the aims of the study, the possible AEs, the procedures and possible hazards to which he/she will be exposed. They will be informed as to the strict confidentiality of their patient data, but that their medical records may be reviewed for trial purposes by authorized individuals other than their treating physician. It will be emphasized that the participation is voluntary and that the patient is allowed to refuse further participation in the protocol whenever he/she wants. This will not prejudice the patient’s subsequent care. Documented informed consent will be obtained for all patients included in the study before they are registered in the study. This will be done in accordance with the national and local regulatory requirements. The informed consent procedure will conform to the ICH guidelines on GCP. This implies that “the written informed consent form will be signed and personally dated by the patient or by the patient’s legally acceptable representative”.The patient material will be stored at the pathology department and the core facility molecular pathology and biobanking at the NKI and the centralized LUMC biobank facility. The PBMCs will be generated from peripheral blood according to local protocol and stored at the immunology division of the NKI-AVL. Material that is not used for current translational research will be stored for at least 20 years after end of study. After 20 years, material will be kept as long as proven useful for scientific research with the NKI-AVL IRB committee as competent authority and in accordance with the NKI-AVL Biobank guidelines.

: Not applicable.

: JB declares to have no competing interests. FH declares to have no competing interests. ET has received honoraria for participation in advisory board meetings for Finch Therapeutics (Somerville). ML declares to have no competing interests. CK declares to have no competing interests. RK declares to have no competing interests. CF declares to have no competing interests. CB reports receiving compensation for advisory roles from BMS, MSD, Roche, Novartis, GSK, AZ, Pfizer, Lilly, GenMab, Pierre Fabre, Third Rock Ventures and receiving research funding from BMS, MSD, Novartis, 4SC and NanoString; furthermore he reports to be co-founder of Immagene BV: all compensations and funding were paid to the institute, except for Third Rock Ventures and Immagene. TS is consultant to Third Rock Ventures and advisor to and stockholder in Allogene Therapeutics, Asher Bio, Celsius, Cell Control, Merus, Neogene Therapeutics, and Scenic Biotech, all outside of the current work. MD declares to have no competing interests. JGH declares to have no competing interests. JK declares to have no competing interests. HV declares to have no competing interests. EK is supported by an unrestricted grant from Vedanta Biosciences. JBH received compensation (all paid to the institute except for Neogene Therapeutics) for advisory roles for Achilles Therapeutics, BioNTech, BMS, Gadeta, Immunocore, Instil Bio, Iovance Biotherapeutics, Ipsen, MSD, Merck Serono, Molecular Partners, Neogene Therapeutics, Novartis, Pfizer, Roche/Genentech, Sanofi, Third Rock Ventures, and T-knife, and has received grants (all paid to the institute) from Amgen, Asher Bio, BioNTech, BMS, MSD, Novartis, and Neogene Therapeutics. The NDFB received an unrestricted grant from Vedanta, Biosciences (Boston), not specific for this study.