Show filters
Hide filters
List of SNIFs submitted to the Member State's Competent Authorities under Directive 2001/18/EC (after 17 October 2002)
Showing result 1 to 25 of total 858 records
Previous page | Next page
Notification Number:
B/NL/24/001
Member State:
Netherlands
Publication:
15/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
University of Amsterdam
Project title:
Local oncolytic virus ORCA-010 administration to sensitize the immune microenvironment of esophageal Adenocarcinoma for chemoradiotherapy
Notification Number:
B/NL/23/015
Member State:
Netherlands
Publication:
15/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
University Medical Center Groningen
Project title:
Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T cells Carrying Reverse Chimeric Antigen Receptors (Allo-RevCAR01-T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123
Notification Number:
B/NL/23/014
Member State:
Netherlands
Publication:
15/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Erasmus MC, University Medical Center Rotterdam
Project title:
Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T cells Carrying Reverse Chimeric Antigen Receptors (Allo-RevCAR01-T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123
Notification Number:
B/ES/24/05
Member State:
Spain
Publication:
12/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
NEC Bio therapeutics GmbH (anteriormente NEC OncoImmunity AS)
Project title:
An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients with Solid Tumors. Study Code NECVAX-NEO1-02-INT
Notification Number:
B/ES/24/02
Member State:
Spain
Publication:
02/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Sanofi-Aventis Recherche et Développement
Project title:
A Phase 1/Phase 2, open-label, dose-escalation, and dose expansion study to evaluate the safety, tolerability, and efficacy of SAR444836, an adeno-associated viral vector-mediated gene transfer of human phenylalanine hydroxylase, in adult participants with phenylketonuria
Notification Number:
B/ES/24/04
Member State:
Spain
Publication:
02/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Boehringer Ingelheim
Project title:
A clinical study (Trial 1504-0003) to evaluate the long-term safety and durability of efficacy of BI 3720931, a replication-deficient, self-inactivating, 3rd generation lentiviral vector gene therapy developed for inhaled treatment of cystic fibrosis.
Notification Number:
B/ES/24/06
Member State:
Spain
Publication:
02/04/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Sana Biotechnology, Inc.
Project title:
A Phase 1 study evaluating SC291, a hypoimmune allogeneic CD19-directed CAR T cell therapy, in relapsed and/or refractory B-cell malignancies (ARDENT)
Notification Number:
B/BE/24/BVW5
Member State:
Belgium
Publication:
28/03/2024
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 efficacy and safety of FIX gene transfer with PF-06838435 (rAAV Spark100-hFIX-R338L) in adult male participants with moderately severe to severe hemophilia B (FIX:C ≤2%) (BeneGene 2)
Notification Number:
B/ES/24/08
Member State:
Spain
Publication:
11/03/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Cabaletta Bio, Inc
Project title:
A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus
Notification Number:
B/ES/23/28
Member State:
Spain
Publication:
26/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Janssen Cilag S.A
Project title:
A Phase 1b Multicenter, Open-label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Notification Number:
B/ES/23/27
Member State:
Spain
Publication:
26/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Janssen Cilag S.A
Project title:
A Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
Notification Number:
B/ES/24/03
Member State:
Spain
Publication:
22/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Boehringer Ingelheim
Project title:
A clinical study (Trial 1504-0001) with BI 3720931, a replication-deficient, self-inactivating, 3rd generation lentiviral vector gene therapy developed for inhaled treatment of cystic fibrosis.
Notification Number:
B/ES/24/07
Member State:
Spain
Publication:
22/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Merck Sharp & Dohme Corp.
Project title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) in Healthy Adults 18 to 50 Years of Age.
Notification Number:
B/AT/05/23
Member State:
Austria
Publication:
19/02/2024
Consent given by the Member State Competent Authority:
Not known
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/HU/24/01
Member State:
Hungary
Publication:
19/02/2024
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/DE/24/PEIP01428
Member State:
Germany
Publication:
16/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
MONIPOL Deutschland GmbH
Project title:
TherVacB – A multi-center phase 1b/2a trial to assess safety, tolerability and immunogenicity of a heterologous protein prime/MVA boost therapeutic hepatitis B vaccine candidate
Notification Number:
B/BE/24/BW4
Member State:
Belgium
Publication:
16/02/2024
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, Open-label, Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9003 in Subjects with Limb Girdle Muscular Dystrophy 2E/R4
Notification Number:
B/ES/23/35
Member State:
Spain
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Fundació Institut de Recerca de l’Hospital de la
Santa Creu i Sant Pau
Project title:
Immunotherapy with differentiated, adult, autologous, peripheral blood T lymphocytes selected by CD62l expression, expanded and transduced (genetically modified) using a lentiviral vector to express a chimeric receptor with anti-CD19 specificity associated with 4-1-BB and CD3ζ co-stimulatory sequences in patients with non-Hodgkin B lymphoma.
Notification Number:
B/ES/24/01
Member State:
Spain
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Celgene Corporation
Project title:
A Phase 1, Multicenter, Single-arm Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS). (Trial number CA061-1006)
Notification Number:
B/ES/23/24
Member State:
Spain
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Cellectis S.A
Project title:
Open-label dose-escalation and dose-expansion study to evaluate the safety,expansion, persistence and clinical activity of UCART22 in patients with relapsed or refractory CD22+B-cell Acute Lymphoblastic Leukemia (B-ALL)
Notification Number:
B/DE/24/PEI P01390
Member State:
Germany
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Kyverna Therapeutics, Inc.
Project title:
A Phase 2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Generalized Myasthenia Gravis (KYSA-6)
Notification Number:
B/DE/24/PEIP01250
Member State:
Germany
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Regeneron Ireland DAC
Project title:
A Two-Part Open-Label Study of REGV131 LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants with Hemophilia B.
Notification Number:
B/DE/24/PEIP01309
Member State:
Germany
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Not known
Name of the Institutes or Companies:
Janssen-Cilag International NV
Project title:
A Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Notification Number:
B/DE/24/PEIP01264
Member State:
Germany
Publication:
14/02/2024
Consent given by the Member State Competent Authority:
Yes 06/03/2024
Name of the Institutes or Companies:
Janssen-Cilag International NV
Project title:
A Phase 1b Multicenter, Open-label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Notification Number:
B/DE/23/PEIP01252
Member State:
Germany
Publication:
26/01/2024
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, Open-label, Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9003 in Subjects with Limb Girdle Muscular Dystrophy 2E/R4