Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
B/BE/17/BVW2
A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases Amgen Ltd
Humans
Insertion of a gene expressing granulocyte-macrophage colony-stimulating factor (hGM-CSF) - Functional deletion of two genes (ICP34.5 and ICP47) of the HSV-1 genome
B/BE/17/BVW1
A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC) Transgene
Humans
Sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
68284528MMY2001
A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3) Celgene
Humans
BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 24 April 2017
.
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia Institut de Recherches Internationales Servier
Humans
chimeric antigen receptor and suicide-ligand (RQR8)
Only notified under the "contained use" procedure. Dossier submitted on 7 April 2017
.
Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus UZ Antwerpen
Humans
Genetic modifications of the nOPV2 vaccine candidates aimed at stabilizing the genetic sequence against reversion compared to the Sabin-2 strain, nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3), nOPV2 candidate 2 (S2/S15domV/CpG40)
B/BE/00/V15
Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v Merial
Horses
haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93
Only notified under the "contained use" procedure. Dossier submitted on 13 October 2000
.
A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi Glaxo Wellcome
Humans
vCP-1452
B/BE/98/B6
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers Schering Plough NV/SA
Humans
wild-type p53 tumor suppressor gene
Only notified under the "contained use" procedure. Dossier submitted on 9 June 1998
.
A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous Rhone-Poulenc Rorer
Humans
Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 4 June 1998
.
Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels Transgene
Humans
Muc-1 and Interleukine 2 (IL-2)
Only notified under the "contained use" procedure. Dossier submitted on 26 March 1998
.
Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha Pasteur Mérieux Connaught
Humans
HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes
