Search the database for deliberate release of GM medicinal products

Displaying 1 - 8 of 8
EU record number Title Company / Sponsor Treated organism Genetic modification
​B/BE/21/BVW4 An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer AMAL Therpeutics Humans VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
bb2121-MM-001 A phase II, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma Celgene Humans BCMA02 (human B cell maturation antigen)-CAR
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. A phase 2, single-arm, multi-cohort, multi-center trial to determine the efficacy and safety of jcar017 in adult subjects with aggressive b-cell non-hodgkin lymphoma Celgene Humans EGFRt en chimeric antigen receptor against CD19
68284528MMY2001 A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3) Celgene Humans BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 23/11/2016. A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia Celgene Humans Chimeric antigen receptor against CD19
B/BE/98/B6 Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers Schering Plough NV/SA 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 Schering Plough NV/SA 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 Schering Plough NV/SA Humans Wild-type p53