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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
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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).