Search the database for deliberate release of GM medicinal products
Displaying 1 - 16 of 16
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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B/BE/24/BVW4 | A phase 3 multinational, open-label, systemic gene delivery study to evaluate the safety and efficacy of SRP-9003 in subjects with limb girdle muscular dystrophy 2E/R4 | Sarepta Therapeutics | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the full-length sarcoglycan-beta (SGCB) gene |
Only notified under the "contained use" procedure. Dossier submitted on 01/03/2024. | A Phase 1b Multicenter, Open-label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non- | Janssen-Cilag International NV | Humans | CD20 CAR |
B/BE/23/BVW2 | A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular De | Janssen-Cilag International NV | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV2 carrying the soluble human CD59 gene |
B/BE/22/BVW6 | A phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION) | Sarepta Therapeutics | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene |
B/BE/22/BVW4 | A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors | Nouscom Srl | Humans | The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens. |
B/BE/21/BVW5 | A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK) | Sarepta Therapeutics | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene |
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/20/BVW5 | Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC | Nouscom Srl | Humans | The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene. |
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. | A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Oth | Janssen-Cilag International NV | Humans | Recombinant Adenovirus serotype 26 and MVA Bavarian Nordic strain |
MB-CART2019.1 | 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 | Humans | CD19 and CD20 chimeric antigen receptor |
B/BE/18/BVW3 | A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck | Oragenics, Inc. | Humans | Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1). |
68284528MMY2003 | A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with R | Janssen-Cilag International NV | Humans | Autologous T cells expressing BCMA (B-cell maturation antigen)-CAR |
68284528MMY2001 | A Phase 1b-2, open-label study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) therapy directed against BCMA in subjets with relapsed or refractory multiple myeloma. Protocol 68284528MMY2001 | Janssen-Cilag International NV | Humans | B-cell maturation antigen (BCMA)-chimeric antigen receptor |
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 29/03/2018. | An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung | Janssen-Cilag International NV | Humans | Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB) |
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2017. | 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) |