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 18/01/2024. A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r NHL) (CP0201-NHL) Galapagos NV Humans BCMA CAR
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018. A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease CRISPR Therapeutic AG Humans Modified cells expressing Hemoglobin F (HbF)