Study 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)
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:
28 oct 2021
EudraCT number:
2021-004158-49
Pharmaceutical study code:
TK-8001
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