Search the database for deliberate release of GM medicinal products
Displaying 1 - 8 of 8
|EU record number
|Company / Sponsor
|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
|Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020.
|A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults
|Themis Bioscience GmbH
|Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV
|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.
|Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) gene
|A phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or resistant B-NHL
|Miltenyi Biotech GmbH
|CD19 and CD20 chimeric antigen receptor
|Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019.
|A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and
|Themis Bioscience GmbH
|Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus
|Phase III trial investigating a AAV vector containing a variant of human factor IX gene administered to adult subjects with severe or moderately-severe hemophilia B
|uniQure biopharma B.V.
|Recombinant adeno associated viral vector containing the wild type modified to express the Padua derivative of human coagulation factor IX cDNA
|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
|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)
|Chimeric antigen receptor against CD19