Part B notifications (experimental releases)

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List of SNIFs submitted to the Member State's Competent Authorities under Directive 2001/18/EC (after 17 October 2002)

Showing result 51 to 75 of total 858 records Previous page | Next page

                        
                            Notification Number: 
                                
                                    B/CZ/23/06
                                
                            Member State: 
                                Czech Republic
                            
                            Publication: 
                                23/10/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Not known                                
                            
                            Name of the Institutes or Companies: 
                            Institute of Hematology and Blood Transfusion (IHBT)                            
                        
                            Project title: 
                            Safety of CAR123 cells manufactured by piggyBac mediated gene transfer for therapy of myeloid malignancies.

                        
                            Notification Number: 
                                
                                    B/ES/23/16
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                16/10/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 10/01/2024                                
                            
                            Name of the Institutes or Companies: 
                            FIBHULP                            
                        
                            Project title: 
                            Phase I trial of memory T cells expressing a chimeric antigen receptor ANTI-NKG2D in children, adolescents and young adults with advanced sarcoma (CAR4SAR)

                        
                            Notification Number: 
                                
                                    B/ES/23/22
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                10/10/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 10/01/2024                                
                            
                            Name of the Institutes or Companies: 
                            Sanofi-Aventis Recherche et Développement                            
                        
                            Project title: 
                            Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus (RSV) vaccine in infants and toddlers.

                        
                            Notification Number: 
                                
                                    B/ES/23/23
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                06/10/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 25/03/2024                                
                            
                            Name of the Institutes or Companies: 
                            AbbVie Inc                            
                        
                            Project title: 
                            A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)

                        
                            Notification Number: 
                                
                                    B/HU/23/02
                                
                            Member State: 
                                Hungary
                            
                            Publication: 
                                03/10/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Not known                                
                            
                            Name of the Institutes or Companies: 
                            AbbVie Inc                            
                        
                            Project title: 
                            A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)

                        
                            Notification Number: 
                                
                                    B/ES/23/09
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                26/09/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 10/01/2024                                
                            
                            Name of the Institutes or Companies: 
                            Quell Therapeutics Limited                            
                        
                            Project title: 
                            A single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant

                        
                            Notification Number: 
                                
                                    B/DE/23/PEI/P00672
                                
                            Member State: 
                                Germany
                            
                            Publication: 
                                20/09/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 02/02/2024                                
                            
                            Name of the Institutes or Companies: 
                            AbbVie Inc                            
                        
                            Project title: 
                            A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)

                        
                            Notification Number: 
                                
                                    B/ES/23/26
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                12/09/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 10/01/2024                                
                            
                            Name of the Institutes or Companies: 
                            Autolus Limited                            
                        
                            Project title: 
                            A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients with CD19-Positive Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL).

                        
                            Notification Number: 
                                
                                    B/DE/23/PEIP00758
                                
                            Member State: 
                                Germany
                            
                            Publication: 
                                11/09/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 27/10/2023                                
                            
                            Name of the Institutes or Companies: 
                            Advesya                            
                        
                            Project title: 
                            An adaptive open-label multicentre Phase 1/2 trial, to determine the REcommended phase 2 dose of CCTx-001, and to assess Safety, tOLerability, and clinical actiVity in patiEnts with relapsed/refractory acute myeloid leukaemia (RESOLVE AML 001).

                        
                            Notification Number: 
                                
                                    B/NL/23/013
                                
                            Member State: 
                                Netherlands
                            
                            Publication: 
                                18/08/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 29/09/2023                                
                            
                            Name of the Institutes or Companies: 
                            Oogziekenhuis Rotterdam                            
                        
                            Project title: 
                            AAV clinical vectors to treat and/or prevent disease

                        
                            Notification Number: 
                                
                                    B/ES/23/18
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                18/08/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 14/11/2023                                
                            
                            Name of the Institutes or Companies: 
                            T3 Pharmaceuticals AG                            
                        
                            Project title: 
                            Clinical Study T3P1001: An open-label, phase I/II study of T3P-Y058-739, a genetically-modified strain of the bacterium Yersinia enterocolitica, in patients with advanced solid tumours

                        
                            Notification Number: 
                                
                                    B/ES/23/14
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                09/08/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 12/09/2023                                
                            
                            Name of the Institutes or Companies: 
                            Boehringer Ingelheim GmbH & Co KG                            
                        
                            Project title: 
                            An open-label, Phase I dose escalation and expansion trial to investigate safety and efficacy of VSV-GP-CD80Fc in patients with advanced solid tumors.

                        
                            Notification Number: 
                                
                                    B/NL/23/011
                                
                            Member State: 
                                Netherlands
                            
                            Publication: 
                                26/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 11/10/2023                                
                            
                            Name of the Institutes or Companies: 
                            Academic Medical Center                            
                        
                            Project title: 
                            Evaluation of safety and efficacy of an intravenous injection of GNT0003, a suspension of recombinant AAV8 viral vector carrying the human UGT1A1 transgene, in patients with Crigler-Najjar syndrome

                        
                            Notification Number: 
                                
                                    B/NL/23/010
                                
                            Member State: 
                                Netherlands
                            
                            Publication: 
                                26/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 28/08/2023                                
                            
                            Name of the Institutes or Companies: 
                            Erasmus MC                            
                        
                            Project title: 
                            A Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T cells (WU-CART-007) in Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/ Lymphoblastic Lymphoma (LBL)

                        
                            Notification Number: 
                                
                                    B/DE/23/PEIP00627
                                
                            Member State: 
                                Germany
                            
                            Publication: 
                                26/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 11/10/2023                                
                            
                            Name of the Institutes or Companies: 
                            Technische Universität Dresden                            
                        
                            Project title: 
                            A Phase I trial to establish the safety and maximum tolerated dose of high-affinity autologous BCMA-targeting CAR T-cells in patients with relapsed and refractory B-cell malignancies (CARLOTTA01)

                        
                            Notification Number: 
                                
                                    B/CZ/23/04
                                
                            Member State: 
                                Czech Republic
                            
                            Publication: 
                                20/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 27/09/2023                                
                            
                            Name of the Institutes or Companies: 
                            LMU Klinikum München                            
                        
                            Project title: 
                            CARMAN: Early treatment intensification in patients with high risk Mantle Cell Lymphoma using CAR-T-cell treatment after an abbreviated induction therapy with Rituximab and Ibrutinib and 6 months Ibrutinib maintenance (Arm A) as compared to standard of care induction and maintenance (Arm B)

                        
                            Notification Number: 
                                
                                    B/DE/23/PEIPB00263
                                
                            Member State: 
                                Germany
                            
                            Publication: 
                                18/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 22/08/2023                                
                            
                            Name of the Institutes or Companies: 
                            LMU Klinikum München                            
                        
                            Project title: 
                            CARMAN: Early treatment intensification in patients with high risk Mantle Cell Lymphoma using CAR-T-cell treatment after an abbreviated induction therapy with Rituximab and Ibrutinib and 6 months Ibrutinib maintenance (Arm A) as compared to standard of care induction and maintenance (Arm B)

                        
                            Notification Number: 
                                
                                    B/CZ/23/05
                                
                            Member State: 
                                Czech Republic
                            
                            Publication: 
                                18/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 19/10/2023                                
                            
                            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 DLBCL

                        
                            Notification Number: 
                                
                                    B/ES/23/17
                                
                            Member State: 
                                Spain
                            
                            Publication: 
                                11/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 14/11/2023                                
                            
                            Name of the Institutes or Companies: 
                            Celgene Corporation                            
                        
                            Project title: 
                            A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS 986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE), trial number CA061-1001

                        
                            Notification Number: 
                                
                                    B/NL/23/009
                                
                            Member State: 
                                Netherlands
                            
                            Publication: 
                                05/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 14/08/2023                                
                            
                            Name of the Institutes or Companies: 
                            Leiden University Medical Center                            
                        
                            Project title: 
                            CART cell therapy for patients with leukemia or lymphoma

                        
                            Notification Number: 
                                
                                    B/NL/23/008
                                
                            Member State: 
                                Netherlands
                            
                            Publication: 
                                04/07/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 07/08/2023                                
                            
                            Name of the Institutes or Companies: 
                            Princess Maxima Center for Pediatric Oncology                            
                        
                            Project title: 
                            Lentiviral or retroviral transduced human cells to prevent or treat disease

                        
                            Notification Number: 
                                
                                    B/CZ/23/03
                                
                            Member State: 
                                Czech Republic
                            
                            Publication: 
                                28/06/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 22/09/2023                                
                            
                            Name of the Institutes or Companies: 
                            Novartis Pharma AG                            
                        
                            Project title: 
                            A randomized, open-label, multicenter phase III trial comparing tisagenlecleucel to standard of care in adult patients with relapsed or refractory follicular lymphoma.

                        
                            Notification Number: 
                                
                                    B/PT/23/02
                                
                            Member State: 
                                Portugal
                            
                            Publication: 
                                20/06/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Not known                                
                            
                            Name of the Institutes or Companies: 
                            PPD Gobal Ltd                            
                        
                            Project title: 
                            An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-23)

                        
                            Notification Number: 
                                
                                    B/DE/23/PEIP00492
                                
                            Member State: 
                                Germany
                            
                            Publication: 
                                20/06/2023
                                
                            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 CC-97540 (BMS 986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE), trial number CA061-1001

                        
                            Notification Number: 
                                
                                    B/NL/23/005
                                
                            Member State: 
                                Netherlands
                            
                            Publication: 
                                16/06/2023
                                
                            Consent given by the Member State Competent Authority: 
                                Yes 18/08/2023                                
                            
                            Name of the Institutes or Companies: 
                            Gezondheidsdienst voor Dieren B.V. (Royal GD)                            
                        
                            Project title: 
                            Vaccination of chickens , under field conditions, with two recombinant herpesvirus of turkey to monitor the immunological responses in time. One herpesvirus with an insection of HA H5 gen of a LPAI virus (Vectormune HVT-AIV) and one existing recombinant herpesvirus of turkey, with a VP2 gene of infectious bursal disease, with a HA H5 gene construct (Vaxxitek HVT-IBD-H5).