Search the database for deliberate release of GM medicinal products

Displaying 1 - 21 of 21
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/20/BVW6 Dossier withdrawn by the notifier Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the human Factor VIII gene
B/BE/20/BVW4 A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy Pfizer Humans Non-replicating recombinant vector derived from adeno-associated virus AAV9, lacking all AAV viral genes and containing a miniaturized version of the human dystrophin gene
Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults Themis Bioscience GmbH Humans Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV
B/BE/19/BVW3 A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Noncentral Nervous System Tumors That are Amenable to Direct Injection Amgen Ltd Humans Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Oth Janssen-Cilag International NV Humans Recombinant Adenovirus serotype 26 and MVA Bavarian Nordic strain
Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019. A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and Themis Bioscience GmbH Humans Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus
68284528MMY2003 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 R Janssen-Cilag International NV Humans Autologous T cells expressing BCMA (B-cell maturation antigen)-CAR
bb2121-MM-001 A phase II, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma Celgene Humans BCMA02 (human B cell maturation antigen)-CAR
68284528MMY2001 A Phase 1b-2, open-label study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) therapy directed against BCMA in subjets with relapsed or refractory multiple myeloma. Protocol 68284528MMY2001 Janssen-Cilag International NV Humans B-cell maturation antigen (BCMA)-chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. A phase 2, single-arm, multi-cohort, multi-center trial to determine the efficacy and safety of jcar017 in adult subjects with aggressive b-cell non-hodgkin lymphoma Celgene Humans EGFRt en chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on 29/03/2018. An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung Janssen-Cilag International NV Humans Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB)
B/BE/17/BVW2 A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases Amgen Ltd Humans Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
68284528MMY2001 A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3) Celgene Humans BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor
B/BE/16/BVW1 A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Amgen Ltd Humans Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
Only notified under the "contained use" procedure. Dossier submitted on 23/11/2016. A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia Celgene Humans Chimeric antigen receptor against CD19
B/BE/15/BVW2 A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (20130232) Amgen Ltd Humans Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/15/BVW1 A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma Amgen Ltd Humans Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/14/BVW1 A phase 2 clinical trial with Talimogene Laherparepvec Amgen Ltd Humans Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/00/V15 Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v Merial Horses haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93
B/BE/99/VW8 Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes. Merial cats env and gag genes of the type A virus of feline leukemia (FELV)
B/BE/97/VW9 Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes. Merial cats env and gag genes of the type A virus of feline leukemia (FELV)