Search the database for deliberate release of GM medicinal products

Displaying 1 - 11 of 11

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
CYAD-211-001	An open-label phase I, multi-center study to determine the recommended dose of the chimeric antigen receptor T-cell treatment CYAD-211 after a non-myeloablative preconditioning chemotherapy in multiple myeloma patients with relapsed or refractory disease.	Celyad	Humans	BCMA-CAR and ShRNA CD3ζ
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
B/BE/18/BVW7	Phase III trial investigating a AAV vector containing a variant of human factor IX gene administered to adult subjects with severe or moderately-severe hemophilia B	uniQure biopharma B.V.	Humans	Recombinant adeno associated viral vector containing the wild type modified to express the Padua derivative of human coagulation factor IX cDNA
B/BE/18/BVW6	Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy	AveXis	Humans	Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene
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 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 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	Novartis Pharma Services AG	Humans	Chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015.	A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)	Catapult Cell Therapy	Humans	Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR)
B/BE/01/V6	Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves.	Pharmacia Animal health	calves	genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT)