|
C/NL/06/01_001
|
Suntory Flowers Limited
|
Application for renewal of consent for marketing approval under Directive 2001/18/EC (Event FLORIGENE®Moonaqua™(FLO-4Ø689-6))
|
09-11-2018
|
Vergunning verleend
|
|
IM-MV 18-013_000
|
UMCG
|
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-seropositive Donors (D+)
|
|
Vergunning verleend
|
|
IM-MV 18-014_000
|
LUMC
|
RAG1‐SCID and RAG2‐SCID CD34+ gene therapy using 3rd generation self‐inactivating (SIN)‐lentiviral vector
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-002_000
|
Universitair Medisch Centrum Utrecht
|
Clinical testing of JNJ-68284528, composed of autologous T cells genetically modified with a lentiviral vector (LVV) to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumour cells
|
02-07-2019
|
Vergunning verleend
|
|
IM-MV 19-003_000
|
Erasmus MC
|
An open-label, Phase I/II multicenter clinical trial of VXM01 in combination with avelumab in patients with progressive glioblastoma and further clinical studies with VXM01 in patients with solid malignancies
|
05-06-2019
|
Vergunning verleend
|
|
IM-MV 19-004_000
|
Erasmus MC
|
Clinical testing of MC2 TCR T cells, an autologous cellular immunotherapy composed of autologous T cells genetically modified ex vivo to express a T cell receptor (TCR) that, upon reinfusion into the patient, recognize and kill MAGE-C2 (MC2)-expressing tumor cells
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-005_000
|
Erasmus MC
|
Phase III study testing bb2121, consisting of autologous T lymphocytes ex-vivo transduced by a replication-defective lentiviral vector to express anti-BCMA chimeric antigen receptors (CAR) to target tumor cells expressing the human B cell maturation antigen (BCMA), in patients with relapsed and refractory multiple myeloma (RRMM)
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-010_000
|
Universitair Medisch Centrum Utrecht
|
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-seropositive Donors (D+)
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-011_000
|
Erasmus MC
|
Clinical testing of JNJ-68284528, composed of autologous T cells genetically modified with a lentiviral vector (LVV) to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumour cells
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-012_000
|
VU medisch centrum
|
Clinical testing of JNJ-68284528, composed of autologous T cells genetically modified with a lentiviral vector (LVV) to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumor cells
|
|
Ontwerpbesluit genomen
|
|
IM-MV 19-013_000
|
LUMC
|
A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-seropositive Donors (D+)
|
|
Ontwerpbesluit genomen
|
