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 24/04/2017. |
A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia |
Humans |
chimeric antigen receptor and suicide-ligand (RQR8) |
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 |
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 |
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. |
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 methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck |
Humans |
Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. |
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 |
Humans |
Wild-type p53 |