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List of SNIFs submitted to the Member State's Competent Authorities under Directive 2001/18/EC (after 17 October 2002)
Notification Number: B/NL/21/024 Member State: Netherlands Publication: 14/10/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Stichting Het Nederlands Kanker Instituut Project title: Application of nuclease-mediated TCR gene editing of an autologous T cell product targeting a limited number of tumor-specific neoantigens for the treatment of advanced solid tumors
Notification Number: B/ES/21/26 Member State: Spain Publication: 14/10/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: T-knife GmbH Project title: First phase 1/2, open-ended,accelerated titration, two-part humanclinical study of TK-8001 (CD8 +autologous T-cell transduced with TCRdirected by MAGE-A1) in patientswith HLA-A*02:01 genotype andadvanced/metastatic MAGE-A1+ solidtumors, who have no other approvedtherapeutic alternative or who are in anincurable state and have received aminimum of two lines of systemic therapy.
Notification Number: B/ES/21/24 Member State: Spain Publication: 14/10/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Ultragenyx Pharmaceutical, Inc. Project title: Clinical Study DTX301-CL301, “A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated GeneTransfer of Human Ornithine Transcarbamylase (OTC) in Patients with Late-Onset OTCDeficiency”
Notification Number: B/ES/21/22 Member State: Spain Publication: 14/10/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: CellPoint B.V. Project title: A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (CP0101-CLL) – Euplagia-1 
Notification Number: B/ES/21/21 Member State: Spain Publication: 14/10/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Nouscom Srl Project title: A Phase I/IIa, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors
Notification Number: B/PT/21/04 Member State: Portugal Publication: 22/09/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Ultragenyx Pharmaceutical, Inc. Project title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Seamless, Adaptive, Safety, Dose-Finding, and Phase 3 Clinical Study of UX701 AAV-Mediated Gene Transfer for the Treatment of Wilson Disease.
Notification Number: B/PT/21/03 Member State: Portugal Publication: 22/09/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Ultragenyx Pharmaceutical, Inc. Project title: Clinical Study DTX301-CL301, “A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated GeneTransfer of Human Ornithine Transcarbamylase (OTC) in Patients with Late-Onset OTCDeficiency.
Notification Number: B/ES/21/23 Member State: Spain Publication: 16/09/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Ultragenyx Pharmaceutical, Inc. Project title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated VirusSerotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With GlycogenStorage Disease Type Ia.
Notification Number: B/NL/21/021 Member State: Netherlands Publication: 19/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Raboud University Medical Center Project title: AAV clinical vectors to treat and/or prevent disease. 
Notification Number: B/NL/21/023 Member State: Netherlands Publication: 19/08/2021 Consent given by the Member State Competent Authority: Yes 19/08/2021 Name of the Institutes or Companies: Leiden University Medical Center Project title: Safety and efficacy of CAR T cells in patients with malignancies.
Notification Number: B/NL/21/022 Member State: Netherlands Publication: 19/08/2021 Consent given by the Member State Competent Authority: Yes 19/08/2021 Name of the Institutes or Companies: Erasmus MC, University Medical Center Rotterdam Project title: Safety and efficacy of CAR T cells in patients with malignancies.
Notification Number: B/NL/21/020 Member State: Netherlands Publication: 12/08/2021 Consent given by the Member State Competent Authority: Yes 23/08/2021 Name of the Institutes or Companies: University Medical Center Groningen Project title: CART cell therapy for patients with leukemia or lymphoma
Notification Number: B/ES/21/20 Member State: Spain Publication: 12/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Hookipa Biotech AG Project title: A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers”Clinical trials.gov identifier: NCT04180215; EudraCT Number: 2019-000907-34)
Notification Number: B/ES/21/16 Member State: Spain Publication: 12/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Ultragenyx Pharmaceutical, Inc. Project title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Seamless, Adaptive,Safety, Dose-Finding, and Phase 3 Clinical Study of UX701 AAV-Mediated GeneTransfer for the Treatment of Wilson Disease.
Notification Number: B/PT/21/02 Member State: Portugal Publication: 11/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Ultragenyx Pharmaceutical, Inc. Project title: Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated Virus Serotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With Glycogen Storage Disease Type Ia.
Notification Number: B/PT/21/01 Member State: Portugal Publication: 11/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Janssen-Cilag International NV Project title: A study comparing VRd followed by ciltacabtagene autoleucel, versus VRd followed by Rd Therapy in Subjects with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.
Notification Number: B_BE_21_BVW2 Member State: Belgium Publication: 11/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Wageningen Bioveterinary Research Project title: Phase I, single-centre, randomized, double blind, placebo-controlled study to assess safety, tolerability and immunogenicity of hRVFV-4s vaccine in healthy subjects.
Notification Number: B-BE-21-BVW3 Member State: Belgium Publication: 11/08/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Prevail Therapeutics, Inc. Project title: Study to Evaluate the Safety and Effects on Progranulin Levels of PR006 in Patients with Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN).
Notification Number: B/NL/21/019 Member State: Netherlands Publication: 22/07/2021 Consent given by the Member State Competent Authority: Yes 22/07/2021 Name of the Institutes or Companies: Erasmus MC Project title: AAV clinical vectors to treat and/or prevent disease.
Notification Number: B/NL/21/017 Member State: Netherlands Publication: 20/07/2021 Consent given by the Member State Competent Authority: Yes 22/07/2021 Name of the Institutes or Companies: AMC Amsterdam Project title: Cells in patients with malignancies.
Notification Number: B/CZ/21/01 Member State: Czech Republic Publication: 13/07/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Kite Pharma, Inc. Project title: Testing the safety and efficacy of KTE-X19 in patients with refractory or relapsed B-cellmalignancies. KTE-X19 is a novel adoptive cellular immunotherapy for cancer wherebyautologous T cells are genetically modified/transduced ex vivo by a replication-deficientretroviral vector (RVV) to express an anti-CD19 chimeric antigen receptor (CAR) on thesurface of T cells to target malignant B cells expressing CD19 antigens.
Notification Number: B/NL/21/016 Member State: Netherlands Publication: 02/07/2021 Consent given by the Member State Competent Authority: Yes 07/06/2021 Name of the Institutes or Companies: Centre for human drug research Project title: AAV clinical vectors to treat and/or prevent disease.
Notification Number: B/NL/21/015 Member State: Netherlands Publication: 02/07/2021 Consent given by the Member State Competent Authority: Yes 07/06/2021 Name of the Institutes or Companies: Sangamo Therapeutics France SAS Project title: Clinical testing of TX200-TR101, an autologous antigen-specific chimeric antigenreceptor (CAR) T regulatory cell therapy.
Notification Number: B/NL/21/014 Member State: Netherlands Publication: 02/07/2021 Consent given by the Member State Competent Authority: Yes 07/06/2021 Name of the Institutes or Companies: Leiden University Medical Center Project title: Clinical testing of TX200-TR101, an autologous antigen-specific chimeric antigenreceptor (CAR) T regulatory cell therapy.
Notification Number: B/SE/21/001242-35 Member State: Sweden Publication: 30/06/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Janssen-Cilag International NV Project title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.
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