Search the database for deliberate release of GM medicinal products
Displaying 1 - 10 of 10
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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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/BVW4 | Importation of doses of V920 for Emergency Use | Merck Sharp & Dohme B.V. | Humans | Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP). |
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 |
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 |
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 |
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 |
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/12/BVW2 | Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure | Celladon | Humans | Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle |
B/BE/08/BVW1 | MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants | MedImmune LLC | Humans | Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F). |
Only notified under the "contained use" procedure. Dossier submitted on 26/03/1998. | Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha | Pasteur Mérieux Connaught | Humans | HLA-A1 restricted CTL epitope of MAGE-1 and MAGE-3 genes |