Study title:
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
Long title:
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 with allogeneic CYAD-101-based CYAD-101 Chimeric antigen receptor T-cells)
Date receipt dossier:
12 Nov 2018
EU record number:
CYAD-N2L-101
EudraCT number:
2018-000927-14
Pharmaceutical study code:
CYAD-101
Company / Sponsor:
Celyad
Phase:
I
Treated organism:
Humans
Indication category:
Cancer therapy
Disease:
Unresectable metastatic colorectal cancer
Therapeutic approach:
Immunotherapy
Genetic modification:
NKG2D-chimeric antigen receptor, the truncated CD19 tag and the TIM8 molecule which interferes with the interaction between the natural TCR and endogenous CD3ζ
Method of transfer of nucleic acid of interest:
Moloney murine leukemia virus
Administered biological material:
Allogeneic T cells retrovirally transduced with a chimeric antigen receptor based on the NKG2D receptor, the truncated CD19 tag and the TIM8 molecule which interferes with the interaction between the natural TCR and endogenous CD3ζ
Route of administration:
Intravenous
Locations in Belgium:
UZ Leuven, Institut Jules Bordet, Universitair ziekenhuis Antwerpen, UZ Gent
Type of procedure:
Contained use only
Current status:
Authorized