Search the database for deliberate release of GM medicinal products

Displaying 1 - 8 of 8
EU record number Title Company / Sponsor Treated organism Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 03/05/2021. Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Kite Pharma Humans CD19-CAR
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
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
B/BE/18/BVW3 A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck Oragenics, Inc. Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
Only notified under the "contained use" procedure. Dossier submitted on 04/05/2018. Phase IIa clinical trial for the evaluation of a vaccin against influenza virus H3N2 FluGen Inc. Humans recombinant H3N2 influenza virus: 6 intern genes of the replication defective A/Puerto Rico/8/34 (PR8) strain with hemagglutinine and neuraminidase from A/Brismane/10/2007 (H3N2) strain
Only notified under the "contained use" procedure. Dossier submitted on 25/04/2018. A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7) Kite Pharma Humans Chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on 22/03/2016. Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). Hookipa Biotech AG Humans Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
B/BE/01/V6 Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. Pharmacia Animal health calves genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT)