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 |
Humans |
CD19-CAR |
B/BE/20/BVW2 |
A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions |
Humans |
The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV. |
EBOVEU001 |
A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium. |
Humans |
Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona) |
FLU10 |
Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model. |
Humans |
Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus |
B/BE/18/BVW5 |
A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus |
Humans |
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin |
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) |
Humans |
Chimeric antigen receptor against CD19 |
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. |
A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) |
Humans |
Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR) |
B/BE/11/BVW2 |
Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer |
Humans |
Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules |
B/BE/03/B3 |
Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers |
Humans |
gene coding for human interleukin 2 |
B/BE/02/B7 |
Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
B/BE/01/B7 |
Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" |
Humans |
sequences coding for the human MUC-1 antigen and IL-2 |
B/BE/98/B6 |
Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers |
Humans |
wild-type p53 tumor suppressor gene |
Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997. |
A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles |
Humans |
Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. |
A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection |
Humans |
Wild-type p53 |