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 |
ADP-0055-001 |
A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors |
Humans |
MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor |
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) |
B/BE/18/BVW6 |
Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy |
Humans |
Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene |
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 21/02/2018. |
Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. |
Humans |
human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4) |
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 |
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) |
Only notified under the "contained use" procedure. Dossier submitted on 14/10/2015. |
A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia |
Humans |
Chimeric antigen receptor against CD19 |
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 |