Search the database for deliberate release of GM medicinal products

Displaying 1 - 5 of 5

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/26/BVW2	An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE)	AAVantgarde Bio UK Ltd.	Humans	Non-replicating recombinant dual vector derived from adeno-associated virus AAV8 carrying functional copies of the ABCA4 gene.
Only notified under the "contained use" procedure. Dossier submitted on 23 August 2024 .	A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma	Kite Pharma	Humans	ddBCMA CAR
Only notified under the "contained use" procedure. Dossier submitted on 3 May 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
B/BE/18/BVW6	Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy	AveXis	Humans	Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene
Only notified under the "contained use" procedure. Dossier submitted on 25 April 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