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)

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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