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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/21/31 Member State: Spain Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: MeiraGTx UK II Limited Project title: Phase 3 Follow-up Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene
Notification Number: B/ES/21/30 Member State: Spain Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: MeiraGTx UK II Limited Project title: Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene
Notification Number: B/DE/21/PEI4443 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Vivet Therapeutics SAS Project title: A Phase I/II, Multicenter, Non-randomized, Open Label, Adaptive Design, 5-year Follow-up, Single Dose-escalation Study of VTX-801 in Adult Patients with Wilson’s Disease.
Notification Number: B/DE/21/PEI4365 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Miltenyi Biomedicine GmbH Project title: Multicenter Phase II trial of MB-CART2019.1 for the Treatment of Patients with relapsed/refractory
Notification Number: B/DE/21/PEI4270 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: uniQure Biopharma B.V. Project title: A Phase Ib/II Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Ascending Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Therapy (AMT-130) in Early Manifest Huntington Disease.
Notification Number: B/DE/21/PEI4241 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Universitätsklinikum Hamburg-Eppendorf Project title: A two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects
Notification Number: B/DE/21/PEI4218 Member State: Germany Publication: 13/01/2022 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: TIGER-CTL019 - Phase II trial of TisaGenlecleucel in Elderly Patients with First-Relapsed or Primary Refractory Agressive B-cell Non-Hodgkin Lymphoma
Notification Number: B/DE/21/PEI4179 Member State: Germany Publication: 13/01/2022 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 JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma
Notification Number: B/DE/21/PEI4565 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Novartis Pharma AG Project title: COAV101A12306: A Phase IIIb, open-label, single-arm, single-dose, multicenter study to evaluate the safety, tolerability and efficacy of gene replacement therapy with intravenous OAV101 (AVXS-101) in pediatric patients with spinal muscular atrophy (SMA)
Notification Number: B/DE/21/PEI4551 Member State: Germany Publication: 13/01/2022 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 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors [IGNYTE]
Notification Number: B/DE/21/PEI4542 Member State: Germany Publication: 13/01/2022 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 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV
Notification Number: B/DE/21/PEI4516 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Pfizer, Inc. Project title: Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C≤1%)
Notification Number: B/DE/21/PEI4494 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Replimune Inc. Project title: A Randomized, Controlled, Open-label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination with RP1 in Patients with Advanced Cutaneous Squamous Cell Carcinoma.
Notification Number: B/DE/20/PEI4094 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Immatics Biotechnologies GmbH Project title: Phase I study evaluating geneticallymodified autologous T cells expressing a T-cell receptor recognizing a cancer/germline antigen in patients with recurrent and/or refractory solid tumors (ACTengine® IMA201-101)
Notification Number: B/DE/20/PEI4198 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Gyroscope Therapeutics Limited Project title: HORIZON: Phase II, open-label, outcomes, assessor-masked multicentre, randomised controlled study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related to macular degeneration
Notification Number: B/DE/20/PEI4135 Member State: Germany Publication: 13/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Novartis Pharma AG Project title: Title of the project: CTL019 - Autologous genetically modified T cells, intravenousinfusion. Treatment of relapsed/refractory B cell
Notification Number: B/BE/21/BVW7 Member State: Belgium Publication: 12/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: SCS Boehringer Ingelheim Comm.V 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/CZ/21/04 Member State: Czech Republic Publication: 07/01/2022 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Janssen-Cilag s.r.o. Project title: 68284528MMY3004 / CARTITUDE-5Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd)followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) TherapyDirected Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd)followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with NewlyDiagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Plannedas Initial Therapy
Notification Number: B/HU/22/01 Member State: Hungary Publication: 07/01/2022 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 andDexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric AntigenReceptor 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 WhomHematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Notification Number: B/NL/21/027 Member State: Netherlands Publication: 03/01/2022 Consent given by the Member State Competent Authority: Yes 12/01/2022 Name of the Institutes or Companies: University Medical Center Utrecht Project title: AAV clinical vectors to treat and/or prevent disease
Notification Number: B/NL/21/026 Member State: Netherlands Publication: 03/01/2022 Consent given by the Member State Competent Authority: Yes 12/01/2022 Name of the Institutes or Companies: Stichting VU medisch centrum Project title: AAV clinical vectors to treat and/or prevent disease
Notification Number: B/SE/2020-003908-14 Member State: Sweden Publication: 21/12/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: BioNTech Cell & Gene Therapies GmbH Project title: Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts toevaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solidtumors
Notification Number: B/IE/21/01 Member State: Ireland Publication: 17/12/2021 Consent given by the Member State Competent Authority: Not known Name of the Institutes or Companies: Gyroscope Therapeutics Limited Project title: EXPLORE: A Phase II, Outcomes, Assessor-Masked Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects with Geographic Atrophy Secondary to Age-Related to Macular Degeneration.HORIZON: A Phase II, Open-Label, Outcomes-Assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. 
Notification Number: B/ES/21/25 Member State: Spain Publication: 30/11/2021 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 (EMBARK)
Notification Number: B/BE/21/BVW6 Member State: Belgium Publication: 22/11/2021 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 antisenseoligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by chronic HepatitisB targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA)therapy”.
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