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Table 1: Approved gene therapy clinical trials in Belgium
(Last revised: March 14, 2016 )

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Click on trial number to get further information on regulatory and clinical data

Trial number
(year of authorisation)
Title

B-GT/1 (1996)

Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system

B-GT/2 (1997) Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of surgery and radiation in the treatment of newly diagnosed, previously untreated gliogblastoma
B-GT/3 (1997) 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
B-GT/4 (1998) 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
B-GT/5 (1998) Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esophageal squamous cell carcinoma or bladder carcinoma
B-GT/6 (1998) Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels
B-GT/7 (1998) A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous cell carcinoma of the head and neck (SCCHN)
B-GT/8 (1998) A phase II/III trial of chemotherapy alone versus chemotherapy plus SCH 58500 in newly diagnosed stage III ovarian and primary peritoneal cancer patients with superior or equal 0.5 cm and inferior or equal 2 cm residual disease following surgery
B-GT/9 (1998) A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection
B-GT/10 (2000) A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination with ALVAC-HIV (vCP-1452) and Remune or placebo while maintaining optimal therapeutic viral suppression
B-GT/11 (2002) Randomized, multicenter, phase II study evaluating two doses of TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer
B-GT/12 (2002) Randomized, multicenter, phase II study evaluating the clinical efficacy of TG4010(MVA-MUC-1-IL-2) in association with chemotherapy in patients with non small cell lung cancer
B-GT/13 (2002) A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrexate in 240 patients with refractory squamous cell carcinoma of the head and neck (SCCHN)
B-GT/14 (2002) A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of the head and neck (SCCHN)
B-GT/15 (2002) Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma
B-GT/16 (2003) A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina
B-GT/17 (2003) A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine
B-GT/18 (2004) Phase I/II multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers
B-GT/19 (2005) A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma
B-GT/20 (2006) A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of Biobypass (ADGVVEGF121.10NH) delivered by NOGATM-guided/MYOSTARTM catheter in "no option" patients with class II-IV stable angina
B-GT/21 (2008) A phase 2a randomized, placebo-controlled, double-blind, multi-center dose escalation study, to evaluate the safety, tolerability, pharmacodynamics and efficacy of AG011, in subjects with moderately active ulcerative colitis
B-GT/22 (2008)

A multi-centre phase I study to evaluate the safety and tolerability of a heterologous prime-boost vaccination with INX102-3697 HBV pDNA/INX102-0557 HBV MVA in healthy volunteers and HBeAg+ chronic hepatitis patients.

B-GT/23 (2008) Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants
B-GT/24 (2009) A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 107 pfu (plaque forming units) of RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 or 3 associated with High Risk HPV infection
B-GT/25 (2010) An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults.
B-GT26 (2011) A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV nonsmall cell lung cancer (NSCLC)
B-GT27 (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
B-GT28 (2012) A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects
B-GT29 (2012) A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
B-GT30 (2012) A multi-center, randomized, double blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination at 5.106 TU, 5.107 TU or 5.108 TU doses to placebo in HIV-1 clade B infected patients under highly active antiretroviral therapy
B-GT31 (2013) A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure (CUPID Phase 2b Trial)
B-GT32 (2014) A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects
B-GT33 (2015) A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated with Talimogene laherparepvec
B-GT34 (2015) A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected, Stage IIIB to IVM1c Melanoma
B-GT35 (2016) A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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