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 |
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 |
Humans |
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1). |
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 04/05/2018. |
Phase IIa clinical trial for the evaluation of a vaccin against influenza virus H3N2 |
Humans |
recombinant H3N2 influenza virus: 6 intern genes of the replication defective A/Puerto Rico/8/34 (PR8) strain with hemagglutinine and neuraminidase from A/Brismane/10/2007 (H3N2) strain |
B/BE/12/BVW2 |
Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure |
Humans |
Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle |
B/BE/12/BVW1 |
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy |
Humans |
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins |