A Phase 1/ 2, 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

Summary

The aim of this study is to determine the safety, tolerability and anti-tumoral activity of autologous T cells transduced with a T cell receptor specific for MAGE-A1 in eligible patients with advanced solid tumors.

Timeline

Start

2022-07-29

Primary completion

2024-01-08

Completion

2024-01-08

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision.”

Publications

• Wermke M, Holderried TAW, Luke JJ, Morris VK, Alsdorf WH, Wetzko K, Andersson BS, Wistuba II, Parra ER, Hossain MB, Grund-Groschke S, Aslan K, Satelli A, Marisetty A, Satam S, Kalra M, Hukelmann J, Kursunel MA, Pozo K, Acs A, Backert L, Baumeister M, Bunk S, Wagner C, Schoor O, Mohamed AS, Mayer-Mokler A, Hilf N, Krishna D, Walter S, Tsimberidou AM, Britten CM. First-in-human dose escalation trial to evaluate the clinical safety and efficacy of an anti-MAGEA1 autologous TCR-transgenic T cell therapy in relapsed and refractory solid tumors. J Immunother Cancer. 2024 Jul 22;12(7):e008668. doi: 10.1136/jitc-2023-008668.

Drugs

Indications