A Phase 1-2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001
Research type
Research Study
Full title
A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) 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
IRAS ID
1004083
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
T-knife GmbH
Eudract number
2021-004158-49
Research summary
Research Summary:
This trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of genetically modified autologous T-cells targeting the tumor antigen MAGE-A1 (TCR-transduced T-cells; TK-8001) in patients with HLA-A*02:01 genotype and advanced-stage, MAGE-A1+ solid tumors in a non-curable state that have received a minimum of two lines of approved systemic therapy.
MAGE-A1 is a cancer testis antigen, exclusively expressed on human cancer cells and in the testis (where no HLA-expression is present). MAGE-A1 has been shown to be widely expressed in various major tumor types and high medical need indications (advanced-stage,
relapsed/refractory tumors with no therapeutic alternative). Importantly, MAGE-A1 follows a strict cancer-testis expression pattern and hast not been described to be expressed in any other healthy tissue outside testis.TK-8001 is a cell therapy product consisting of autologous CD8+ T-cells retrovirally transduced with a high-affinity and high-specificity TCR generated with the humanized huTCR platform targeting a MAGE-A1 epitope and enabling elimination of MAGE-A1+ tumor cells.
Lay Summary of Results:
During the study, no patient experienced a dose limiting toxicity (DLT), and no suspected unexpected serious adverse reactions (SUSARs) or serious adverse events related to TK-8001 were observed. However, TK-8001 did not shown the desired level of efficacy to warrant continued investigation.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0166
Date of REC Opinion
14 Dec 2021
REC opinion
Further Information Favourable Opinion