A Phase 1/2, First-in-Human, Open-Label, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/Metastatic MAGE-A1+ Solid Tumors (IMAG1NE)
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- STATUS
- Recruiting
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- End date
- Jun 10, 2037
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- participants needed
- 48
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- sponsor
- T-knife GmbH
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.
Description
This is a Phase 1/2, first-in-human, open-label, 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 as per the Investigator's assessment and have received a minimum of two lines of systemic therapy. The trial will consist of a Phase 1 Part and a Phase 2 Part. In the Phase 1 Part (dose-escalation), at least 6 patients and up to 18 patients (if DLT occurs) will receive escalating doses of TK-8001. In the Phase 2 Part (expansion), up to 30 patients will receive TK-8001 to further evaluate the efficacy and safety of TK-8001 and to confirm the RP2D. Both the Phase 1 Part (dose-escalation) and Phase 2 Part (expansion) of the trial will consist of the following periods: Screening and Leukapheresis Period, Screening II, Conditioning Period, TK-8001 Treatment Period, DLT Monitoring Period, Core Follow-up Period (Year 1), Long-term Follow-up Period (Year 2 - 15).
Details
| Condition | Advanced Solid Tumors |
|---|---|
| Treatment | Autologous CD8+ T-cells, transduced with MAGE-A1 directed TCR |
| Clinical Study Identifier | NCT05430555 |
| Sponsor | T-knife GmbH |
| Last Modified on | 4 October 2022 |
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