Search the database for deliberate release of GM medicinal products

Displaying 1 - 3 of 3
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/25/BVW3 Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) with Severe or Moderately Severe Hemophilia B CSL Behring LLC Humans Recombinant adeno associated viral vector containing the codon-optimised human PADUA factor IX (FIX) gene
Only notified under the "contained use" procedure. Dossier submitted on 02/09/2022. A single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant Quell Therapeutics Limited Humans BCMA CAR; shRNA CD3ζ; tCD34
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).