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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 76 to 100 of total 858 records
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Notification Number:
B/CZ/23/02
Member State:
Czech Republic
Publication:
13/06/2023
Consent given by the Member State Competent Authority:
Yes 19/10/2023
Name of the Institutes or Companies:
Parexel International Czech Republic s.r.o.
Project title:
EMN28/68284528MMY3005/ CARTITUDE-6: A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible
Notification Number:
B/DE/23/PEIP00408
Member State:
Germany
Publication:
13/06/2023
Consent given by the Member State Competent Authority:
Yes 25/07/2023
Name of the Institutes or Companies:
Prevail Therapeutics, Inc.
Project title:
An Open-label, Dose-Finding, Phase 1/2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients with Peripheral Manifestations of Gaucher Disease.
Notification Number:
B/DE/23/PEIP00461
Member State:
Germany
Publication:
09/06/2023
Consent given by the Member State Competent Authority:
Yes 18/07/2023
Name of the Institutes or Companies:
Replimune Inc.
Project title:
A Phase 2, Open-label, Multicenter Study Investigating RP3 Oncolytic Immunotherapy in Combination with First- or Second-line Therapy in Patients with Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma
Notification Number:
B/NL/23/006
Member State:
Netherlands
Publication:
Consent given by the Member State Competent Authority:
Yes 07/08/2023
Name of the Institutes or Companies:
Stichting Het Nederlands Kanker Instituut
Project title:
A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients with HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors that Either Have No Further Approved Therapeutic Alternative(s) or are not Eligible for them or are in a Non- Curable State and Have Received a Minimum of Two Lines of Systemic Therapy
Notification Number:
B/ES/23/15
Member State:
Spain
Publication:
08/06/2023
Consent given by the Member State Competent Authority:
Yes 19/07/2023
Name of the Institutes or Companies:
Fundación del Instituto de Estudios de Ciencias de la Salud de Castilla y León (IECSCYL)
Project title:
Multicenter phase I/IIa study of infusion of autologous peripheral blood lymphocytes expanded and genetically modified by transposons of the Sleeping Beauty family to express a chimeric antigenic receptor with anti-CD19 specificity conjugated with the co-stimulatory region4-1BB and CD3ζ and huEGFRt signal transmission (TranspoCART19) in patients with relapsed or refractory B-cell lymphoma.
Notification Number:
B/ES/23/04
Member State:
Spain
Publication:
08/06/2023
Consent given by the Member State Competent Authority:
Yes 19/07/2023
Name of the Institutes or Companies:
Vaccitech Limited
Project title:
A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men with Biochemical Recurrence after Definitive Local Therapy for Prostate Cancer
Notification Number:
B/ES/23/11
Member State:
Spain
Publication:
26/05/2023
Consent given by the Member State Competent Authority:
Yes 19/07/2023
Name of the Institutes or Companies:
Replimune Inc.
Project title:
A Phase 2 Clinical Trial Investigating Oncolytic Immunotherapy in Combination with Atezolizumab and Bevacizumab for the Treatment of Patients with Advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma
Notification Number:
B/CZ/23/01
Member State:
Czech Republic
Publication:
26/05/2023
Consent given by the Member State Competent Authority:
Yes 19/10/2023
Name of the Institutes or Companies:
Bristol-Myers Squibb
Project title:
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Notification Number:
B/ES/23/08
Member State:
Spain
Publication:
26/05/2023
Consent given by the Member State Competent Authority:
Yes 19/07/2023
Name of the Institutes or Companies:
Celgene Corporation
Project title:
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Notification Number:
B/ES/23/12
Member State:
Spain
Publication:
19/05/2023
Consent given by the Member State Competent Authority:
Yes 19/07/2023
Name of the Institutes or Companies:
Replimune Inc.
Project title:
A Phase 2, Open-label, Multicenter Study Investigating RP3 in Combination with Other Therapy in Patients with Locoregionally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Notification Number:
B/RO/23/02
Member State:
Romania
Publication:
17/05/2023
Consent given by the Member State Competent Authority:
Yes 04/08/2023
Name of the Institutes or Companies:
Bristol-Myers Squibb
Project title:
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Notification Number:
B/DE/23/PEIP00410
Member State:
Germany
Publication:
15/05/2023
Consent given by the Member State Competent Authority:
Yes 26/06/2023
Name of the Institutes or Companies:
Replimune Inc.
Project title:
A Phase 2, Open-label, Multicenter Study Investigating RP3 in Combination with Other Therapy in Patients with Locoregionally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Notification Number:
B/HU/23/01
Member State:
Hungary
Publication:
27/04/2023
Consent given by the Member State Competent Authority:
Yes 15/06/2023
Name of the Institutes or Companies:
Janssen-Cilag International NV
Project title:
HU: A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Notification Number:
B/PT/23/01
Member State:
Portugal
Publication:
24/04/2023
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Janssen-Cilag International NV
Project title:
PT: A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Notification Number:
B/NL/23/007
Member State:
Netherlands
Publication:
25/05/2023
Consent given by the Member State Competent Authority:
Yes 20/06/2023
Name of the Institutes or Companies:
Leiden University Medical Center
Project title:
Lentiviral or retroviral transduced human cells to prevent or treat disease
Notification Number:
B/DE/23/PEI5235
Member State:
Germany
Publication:
17/04/2023
Consent given by the Member State Competent Authority:
Yes 12/06/2023
Name of the Institutes or Companies:
University Hospital Tübingen
Project title:
Comparing safety and protective efficacy of the whole Plasmodium falciparum sporozoite chemoprophylaxis vaccine candidate PfSPZ-CVac and prime- target vaccination with viral vectored vaccine candidate regime MVA ME-TRAP/ ChAd63 ME-TRAP in malaria-naïve, healthy adult volunteers in Germany.
Notification Number:
B/DE/23/PEIPB00305
Member State:
Germany
Publication:
14/04/2023
Consent given by the Member State Competent Authority:
Yes 09/06/2023
Name of the Institutes or Companies:
Allogene Therapeutics Inc
Project title:
A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With Fludarabine, Cyclophosphamide, And ALLO-647, Vs. Fludarabine And Cyclophosphamide Alone, In Subjects With Relapsed/ Refractory Large B-Cell Lymphoma (LBCL) Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Notification Number:
B/ES/23/07
Member State:
Spain
Publication:
04/04/2023
Consent given by the Member State Competent Authority:
Yes 19/07/2023
Name of the Institutes or Companies:
Allogene Therapeutics Inc
Project title:
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, And Cellular Kinetics/Pharmacodynamics Of ALLO-501A, An Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, An Anti-CD52 Monoclonal Antibody, In Subjects With Relapsed/ Refractory Large B-Cell Lymphoma (LBCL)
Notification Number:
B/ES/23/05
Member State:
Spain
Publication:
31/03/2023
Consent given by the Member State Competent Authority:
Yes 12/06/2023
Name of the Institutes or Companies:
AMAL Therapeutics S.A.
Project title:
A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
Notification Number:
B/BE/23/BVW2
Member State:
Belgium
Publication:
23/03/2023
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Janssen-Cilag International NV
Project title:
BE: A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Notification Number:
B/DE/23/PEI/PB00260
Member State:
Germany
Publication:
17/03/2023
Consent given by the Member State Competent Authority:
Yes 03/05/2023
Name of the Institutes or Companies:
Janssen-Cilag International NV
Project title:
DE: A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Notification Number:
B/DE/23/PEIP00270
Member State:
Germany
Publication:
14/03/2023
Consent given by the Member State Competent Authority:
Yes 18/04/2023
Name of the Institutes or Companies:
ViGeneron GmbH
Project title:
A Prospective, Open-label, Phase 1b, Single-arm, Safety Study of an Intravitreal Application of a Recombinant Adeno-associated Virus Vector Expressing CNGA1 (AAV2.NN-CNGA1) in Patients with Retinitis Pigmentosa Due to CNGA1 Mutations
Notification Number:
B/ES/23/03
Member State:
Spain
Publication:
13/03/2023
Consent given by the Member State Competent Authority:
Yes 14/04/2023
Name of the Institutes or Companies:
Adaptimmune LLC
Project title:
A PHASE 2, OPEN-LABEL, RANDOMIZED, NON-COMPARATIVE CLINICAL TRIAL OF ADP-A2M4CD8 MONOTHERAPY AND IN COMBINATION WITH NIVOLUMAB IN SUBJECTS WITH RECURRENT OVARIAN CANCERS (SURPASS-3 STUDY/ GOG-3084)
Notification Number:
B/ES/23/06
Member State:
Spain
Publication:
13/03/2023
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Targovax Oy
Project title:
An Open-Label, Two-Part, Dose-Exploration and Multiple Expansion, Phase 2 Study of ONCOS-102 in Combination with Novel Immune-Targeted Anti-Cancer Agents in Patients with Unresectable or Metastatic Cutaneous Melanoma Resistant to Anti-PD-(L)1 Treatment
Notification Number:
B/NL/23/004
Member State:
Netherlands
Publication:
13/03/2023
Consent given by the Member State Competent Authority:
Yes 17/03/2023
Name of the Institutes or Companies:
Erasmus MC, University Medical Center Rotterdam
Project title:
Lentiviral or retroviral transduced human cells to prevent or treat disease