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 |
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 |
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) |
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/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) |
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 28/10/2021. |
A Phase I/II, First-in-human, open-label, accelerated-titration, two-part clinical trial of TK-8001 in patients with HLA-A*02:01 genotype and advanced-stage/metastatic, MAGE-A1 + solid tumors that either have no further approved therapeutic alternative(s) |
Humans |
chimere MAGE-A1 TCRs |
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 |
Humans |
Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |
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 |
Humans |
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 |
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 |
Humans |
Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen |
Only notified under the "contained use" procedure. Dossier submitted on 23/04/2012. |
Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia |
Humans |
-Thymidine Kinase (HSV-Tk)
- selection marker |
B/BE/07/BVW1 |
Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis |
Humans |
Gene coding for the human interleukin-10 (hIL-10) |
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 |
Horses |
haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93 |
B/BE/99/VW8 |
Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
cats |
env and gag genes of the type A virus of feline leukemia (FELV) |
B/BE/97/VW9 |
Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes. |
cats |
env and gag genes of the type A virus of feline leukemia (FELV) |