Search the database for deliberate release of GM medicinal products

Displaying 1 - 6 of 6

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/25/BVW9	Phase 1/2 Investigation Of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (PIONEER-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002	VectorY Therapeutics B.V.	Humans	Non-replicating recombinant AAV vector with a AAV5.2 capsid and carrying the transgene corresponding to the single-chain variable fragment that binds to human TDP-43
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/20/BVW2	A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions	Vaccitech Limited	Humans	The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV.
FLU10	Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model.	Vaccitech Limited	Humans	Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus
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