Search the database for deliberate release of GM medicinal products

Displaying 1 - 13 of 13
EU record number Title Company / Sponsor Treated organism Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant Sangamo therapeutics Humans chimeric antigen receptor specific to the donor HLA A*2
CYAD-N2T-005 An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplasic syndrome patient (DEPLETHINK - Celyad Humans NKG2D-chimeric antigen receptor
CYAD-02-001 An open-label, phase I, multi-center study to determine in relapsed/refractory acute myeloid leukemia or myelodysplasic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-0 Celyad Humans NKG2D-chimeric antigen receptor, ShRNA targeting the endogenous RNA of NKG2D ligands MICA and MICB and truncated CD19 reporter protein
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
CYAD-N2L-101 An open-label, Phase I study to assess the safety of multiple doses of CYAD-101, administered after standard FOLFOX chemotherapy in patients with unresectable metastatic colorectal cancer (alloSHRINK-study-Standard cHemotherapy Regimen and Immunotherapy w Celyad Humans NKG2D-chimeric antigen receptor, the truncated CD19 tag and the TIM8 molecule which interferes with the interaction between the natural TCR and endogenous CD3ζ
CYAD-N2T-006 An open-label, phase I study to assess the safety of NKR-2 treatment administrated concurrently with 5-azacytidine in tretment-naïve acute myeloid leukemia or myelodysplastic syndrome patients not candidates for intensive therapy (EPITHINK - EPIgenetic dr Celyad Humans NKG2D-chimeric antigen receptor
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 07/04/2017. Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus UZ Antwerpen 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 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
Only notified under the "contained use" procedure. Dossier submitted on 25/10/2016. A multinational, open-label, dose escalation Phase I/II study to assess the safety and clinical activity of multiple administrations of NKR-2 in patients with different metastatic tumor types Celyad Humans NKG2D-chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 22/03/2016. Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). Hookipa Biotech AG Humans Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
B/BE/12/BVW1 A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy TheraVectys Humans genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins