B/BE/21/BVW9 |
Dossier withdrawn by the notifier |
Humans |
V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30) |
Only notified under the "contained use" procedure. Dossier submitted on 28/10/2021. |
A Phase I/II, First-in-human, open-label, accelerated-titration, two-part clinical trial of TK-8001 in patients with HLA-A*02:01 genotype and advanced-stage/metastatic, MAGE-A1 + solid tumors that either have no further approved therapeutic alternative(s) |
Humans |
chimere MAGE-A1 TCRs |
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. |
Humans |
BCMA-CAR and ShRNA CD3ζ |
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 |
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 - |
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 |
Humans |
NKG2D-chimeric antigen receptor, ShRNA targeting the endogenous RNA of NKG2D ligands MICA and MICB and truncated CD19 reporter protein |
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 |
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 |
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 |
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). |
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 |
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 |
Humans |
Chimeric antigen receptor against CD19 |
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2014. |
A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects |
Humans |
gene expressing certolizumab |
Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012. |
A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects |
Humans |
Human Trefoil Factor 1 |
Only notified under the "contained use" procedure. Dossier submitted on 11/07/2002. |
A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina |
Humans |
human FGF-4 |