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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/ES/22/11 Member State: Spain Publication: 17/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Janssen Vaccines & Prevention B.V. Project title: “A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older” 
Notification Number: B/ES/22/02 Member State: Spain Publication: 17/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Celgene Corporation Project title: A Phase 1, Multicenter, Open-Label Study Of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL
Notification Number: B/ES/22/15 Member State: Spain Publication: 13/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: GlaxoSmithKline AB Project title: Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T cells, alone or in combination with other agents, in Participants with Advanced Tumors” (209012)
Notification Number: B/ES/22/09 Member State: Spain Publication: 13/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: GlaxoSmithKline AB Project title: Master Protocol to Assess the Safety and Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T cells, alone or in combination with other agents, in Participants with Advanced Tumors” (209012)
Notification Number: B/DE/22/PEI4820 Member State: Germany Publication: 13/06/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Universitätsklinikum Carl Gustav Carus an der TU Dresden Project title: Long-term Follow-up Study for Participants of Kite Sponsored Interventional Studies Treated With Gene-Modified Cells
Notification Number: B/DE/22/PEI4693 Member State: Germany Publication: 13/06/2022 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 Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy 
Notification Number: B/NL/22/002 Member State: Netherlands Publication: 31/05/2022 Consent given by the Member State Competent Authority: Yes 24/05/2022 Name of the Institutes or Companies: Janssen-Cilag International NV Project title: Clinical study 68284528MMY2001: A Phase 1b/2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma.
Notification Number: B/DE/22/PEI4766 Member State: Germany Publication: 17/05/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: University of Tübingen Project title: A phase Ia, dose-finding study to assess the safety and immunogenicity of an Orf virusbased COVID-19 vaccine booster (Prime-2-CoV_Beta) in healthy adults (e) Proposed period of release Q1/Q2 2022 
Notification Number: B/DE/22/PEI4763 Member State: Germany Publication: 17/05/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Speransa Therapeutics Project title: A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins (ORFEUS Study)
Notification Number: B/DE/22/PEI4702 Member State: Germany Publication: 17/05/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: GlaxoSmithKline Biologicals SA Project title: “A phase 2, single-blinded, randomized, controlled multi-country study to evaluate the safety, reactogenicity, efficacy and immune response following sequential treatment with an anti-sense 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”.
Notification Number: B/DE/22/PEI4702 Member State: Germany Publication: 17/05/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: GlaxoSmithKline Biologicals SA Project title: “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”. 
Notification Number: B/NL/22/001 Member State: Netherlands Publication: 04/05/2022 Consent given by the Member State Competent Authority: Yes 09/05/2022 Name of the Institutes or Companies: Stichting VU medisch centrum Project title: A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillo- mavirus 16 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/DE/22/PEI4670 Member State: Germany Publication: 19/04/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Sangamo Therapeutics France SAS Project title: A Multicentre, Open-Label, Single Ascending Dose, Dose Ranging, Phase I/IIa Studyto Evaluate the Safety and Tolerability of an Autologous Antigen-Specific ChimericAntigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor RenalTransplant Recipients
Notification Number: B/DE/22/PEI4669 Member State: Germany Publication: 23/03/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Vertex Pharmaceuticals Incorporated Project title: Clinical study VX21-CTX001-141 titled: “A Phase 3 Study to Evaluate the Safety andEfficacy of a Single Dose of CTX001 in Pediatric Subjects With Transfusion-Dependent β-Thalassemia”
Notification Number: B/DE/22/PEI4636 Member State: Germany Publication: 22/03/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Vertex Pharmaceuticals Incorporated Project title: Clinical study VX21-CTX001-151 titled: “A Phase 3 Study to Evaluate the Safety andEfficacy of a Single Dose of CTX001 in Pediatric Subjects With Severe Sickle CellDisease”
Notification Number: B/ES/22/06 Member State: Spain Publication: 08/03/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Forge Biologics, Inc Project title: FBX-101-REKLAIM: A Phase 1b Clinical Study of Intravenous AAVrh10 Vector Expressing GALC in Krabbe Subjects Who Previously Received Hematopoietic Stem Cell Transplantation
Notification Number: B/ES/22/08 Member State: Spain Publication: 08/03/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Instituto de Ganadería de Montaña (IGM) - CSIC Project title: Immune response and vaccine efficacy in sheep vaccinated with the candidate Rev1Δwzm.
Notification Number: B/ES/22/07 Member State: Spain Publication: 08/03/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Replimune Inc. Project title: An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors [RP3-301]
Notification Number: B/PT/22/02 Member State: Portugal Publication: 03/03/2022 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/IT/22/01 Member State: Italy Publication: 28/02/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Arcoblu s.r.l. Project title: Vaccination of chickens with a herpes virus of turkey vaccine carrying a VP2 gene of infectious bursal disease virus and a F gene of Newcastle disease virus
Notification Number: B/ES/21/32 Member State: Spain Publication: 10/02/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Institut d’Investigació Biomédica de Bellvitge (IDIBELL Project title: Title of the project: Phase I/II stUdy of ALoCelyvir in patientS with mEtastatic Melanonave (PULSE-UM)
Notification Number: B/NL/21/025 Member State: Netherlands Publication: 08/02/2022 Consent given by the Member State Competent Authority: Yes 06/04/2022 Name of the Institutes or Companies: Stichting Het Nederlands Kanker Instituut Project title: A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillo- mavirus 16 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/22/04 Member State: Spain Publication: 04/02/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Novartis Pharma AG Project title: A Phase 2 study of PHE885, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiplemyeloma
Notification Number: B/BE/21/BVW9 Member State: Belgium Publication: 02/02/2022 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 theSafety and Immunogenicity of ThreeDifferent Potency Levels of V181(Dengue Quadrivalent VaccinerDENVΔ30 [live, attenuated]) inHealthy Adults
Notification Number: B/DE/22/PEI4591 Member State: Germany Publication: 02/02/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Valo Therapeutics Project title: A Phase I, open-label, non-randomized study to evaluate the safety and immune activity ofPeptiCRAd-1, a tumor-specific peptide coated conditionally replicating adenovirus, incombination with immune checkpoint inhibitor pembrolizumab in patients with injectablesolid tumors in indications known to express NY-ESO-1 and MAGE-A3
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