Long title
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) or are in a non-curable state and have received a minimum of two lines of systemic therapy
Date receipt dossier
EudraCT number
2021-004158-49
Company / Sponsor
T-Knife GmbH
Phase
I/II
Treated organism
Humans
Indication category
Cancer therapy
Disease
Solid tumors
Therapeutic approach
Immunotherapy
Genetic modification
chimere MAGE-A1 TCRs
Method of transfer of nucleic acid of interest
Retroviral vector
Administered biological material
Autologous T cells transduced with retroivral vector coding for a chimere MAGE-A1 TCRs
Route of administration
Intravenous
Locations in Belgium
UZ Gent
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
TK-8001