Search the database for deliberate release of GM medicinal products

Displaying 1 - 7 of 7

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/21/BVW2	Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects	Wageningen Bioveterinary Research (Larissa Consortium)	Humans	hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments.
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
B/BE/19/BVW2	A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels Receiving Prophylactic FVIII	BioMarin Pharmaceutical Inc.	Humans	Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) gene
Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018.	A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy	Immune Design	Humans	Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen
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 14/10/2015.	A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia	Novartis Pharma Services AG	Humans	Chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on 01/02/2005.	A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma	Ark Therapeutics Ltd	Humans	Thymidine Kinase (HSV-TK1)