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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/RO/22/01 Member State: Romania Publication: 22/09/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: PPD România SRL, part of Thermo Fisher Scientific Project title: The release of the Genetically Modified Organism (GMO) will take place during a clinical study entitled: “A phase 2, single-blinded, randomized, controlled multi-country study to evaluate the safety, reactogenicity, efficacy and immune response following sequential treatment with an antisense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy”. EudraCT number of the study is: 2021-003567-10 and the Applicant’s study code is: 217023 (abbreviated title: TH HBV ASO-001)
Notification Number: B/ES/22/20 Member State: Spain Publication: 19/09/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: BioMarin Pharmaceutical Inc. Project title: A Phase 1/2, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of BMN 331, an Adeno-Associated Virus (AAV) Vector-Mediated Gene Transfer of Human SERPING1, in Subjects with Hereditary Angioedema (HAE) due to Human C1 Esterase Inhibitor (C1-INH) Deficiency
Notification Number: B/ES/22/19 Member State: Spain Publication: 19/09/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: F. Hoffmann-La Roche, Ltd. Project title: A two-part, open-label systemic gene delivery study to evaluate the safety and expression of RO7494222 (SRP-9001) in subjects under the age of four with Duchenne Muscular Dystrophy 
Notification Number: B/ES/22/13. Member State: Spain Publication: 19/09/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Prevail Therapeutics, Inc. Project title: Clinical Study J3Z-MC-OJAE: An Open-label, Dose-Finding, Phase 1/2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients with Peripheral Manifestations of Gaucher Disease.
Notification Number: B/DE/22/PEI4638 Member State: Germany Publication: 19/09/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: T-knife GmbH Project title: A Phase 1/2, First-in-Human, Open-Label, Accelerated Titration, Two-part Clinical Trial of TK-8001 (MAGE-A1-directed TCR-Transduced Autologous CD8+ T cells) in Subjects with HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors that Either have no Approved Therapeutic Alternative(s) Anymore or are in NonCurable State and have Received a Minimum of Two Lines of Systemic Therapy.
Notification Number: B/DE/22/PEI4815 Member State: Germany Publication: 08/09/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Kite Pharma, Inc. Project title: A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma 
Notification Number: B/SK/22/01 Member State: Slovakia Publication: 31/08/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: BlueSky Immunotherapies GmbH Project title: Randomised, double-blind, placebocontrolled phase 1 dose-escalation study of FluBHPVE6E7 in HPV16-infected women with normal cytology, ASC-US or low-grade CIN (Protocol no.: BS-02)
Notification Number: B/DE/22/PEI4827 Member State: Germany Publication: 30/08/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Vertex Pharmaceuticals Incorporated Project title: Clinical study VX21-CTX001-161 titled: “A Phase 3b Study to Evaluate Efficacy and Safety of a Single Dose of Autologous CRISPR Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (CTX001) in Subjects with TransfusionDependent β-Thalassemia or Severe Sickle Cell Disease
Notification Number: B/ES/22/10 Member State: Spain Publication: 29/08/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Leiden University Medical Center Project title: Phase II clinical trial of autologous hematopoietic stem cell gene therapy for the treatment of severe combined immunodeficiency due to RAG1 gene deficiency. “PHASE I/II CLINICAL TRIAL OF AUTOLOGOUS HEMATOPOIETIC STEM CELL GENE THERAPY FOR RAG1-DEFICIENT SEVERE COMBINED IMMUNODEFICIENCY” (EudraCT: 2019-002343-14).
Notification Number: B/ES/22/17 Member State: Spain Publication: 29/08/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Sarepta Therapeutics Inc Project title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION) 
Notification Number: B/NL/22/007 Member State: Netherlands Publication: 26/07/2022 Consent given by the Member State Competent Authority: Yes 27/07/2022 Name of the Institutes or Companies: Leiden University Medical Center Project title: A phase I/II trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive patients with relapsed or refractory NPM1-mutated AML
Notification Number: B/NL/22/003 Member State: Netherlands Publication: 26/07/2022 Consent given by the Member State Competent Authority: Yes 27/07/2022 Name of the Institutes or Companies: Erasmus MC Project title: Multicenter, Open-label, Adaptive Design Phase I Trial with Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination with CD123 Target Module (TM123) for the Treatment of Patients with Hematologic and Lymphatic Malignancies Positive for CD123
Notification Number: B/DE/22/PEI4755 Member State: Germany Publication: 22/07/2022 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 Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Patients with Late-Onset OTC Deficiency”
Notification Number: B/ES/22/12 Member State: Spain Publication: 14/07/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Boehringer Ingelheim Project title: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors
Notification Number: B/DE/22/PEI4817 Member State: Germany Publication: 13/07/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Bavarian Nordic GmbH Project title: Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA BN-RSV Vaccine in in Adults ≥60 years of Age
Notification Number: B/AT/22/01 Member State: Austria Publication: 08/07/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Universitätsklinikum AKH Wien Project title: Multicenter Phase II trial of MB-CART2019.1 for the Treatment of Patients with relapsed/refractory DLBCL
Notification Number: B/DE/22/PEI4746 Member State: Germany Publication: 07/07/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Novartis Pharma AG Project title: PHE885 – Autologous genetically modified T cells, intravenous administration. Treatment of relapsed/refractory malignancies
Notification Number: B/NL/22/008 Member State: Netherlands Publication: 05/07/2022 Consent given by the Member State Competent Authority: Yes 06/07/2022 Name of the Institutes or Companies: University Medical Center Utrecht Project title: Trials to assess safety, tolerability and recommended phase 2 dose (RP2D) of NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents, in HLA-A*02+ participants with NY-ESO-1 and/or LAGE-1a positive advanced tumors
Notification Number: B/NL/22/006 Member State: Netherlands Publication: 04/07/2022 Consent given by the Member State Competent Authority: Yes 04/07/2022 Name of the Institutes or Companies: University Medical Center Groningen Project title: Trials to assess safety, tolerability and recommended phase 2 dose (RP2D) of NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents, in HLA-A*02+ participants with NY-ESO-1 and/or LAGE-1a positive advanced tumors
Notification Number: B/NL/22/005 Member State: Netherlands Publication: 28/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Stichting VU medisch centrum Project title: CART cell therapy for patients with leukemia or lymphoma
Notification Number: B/NL/22/004 Member State: Netherlands Publication: 28/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Academic Medical Center Amsterdam, the Netherlands Project title: CART cell therapy for patients with leukemia or lymphoma
Notification Number: B/DE/22/PEI4772 Member State: Germany Publication: 24/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Novartis Pharma AG Project title: YTB323 – Phase 1, open label, multicenter dose escalation study of YTB323 in adult patients with CLL/SLL, DLBCL and ALL
Notification Number: B/DE/22/PEI4674 Member State: Germany Publication: 21/06/2022 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 Virus Serotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With Glycogen Storage Disease Type Ia
Notification Number: B/DE/22/PEI4743 Member State: Germany Publication: 21/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Merck Sharp & Dohme Corp. Project title: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) in Healthy Adults 
Notification Number: B/ES/22/18 Member State: Spain Publication: 17/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: VCN Biosciences S.L. Project title: “A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN01 in Patients with Metastatic Pancreatic Canc
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