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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/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
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”.
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