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 (IMAG1NE)
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ClinicalTrials.gov Identifier: NCT05430555 |
Recruitment Status :
Terminated
(Sponsor decision.)
First Posted : June 24, 2022
Last Update Posted : February 7, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | June 1, 2022 | ||||
First Posted Date ICMJE | June 24, 2022 | ||||
Last Update Posted Date | February 7, 2024 | ||||
Actual Study Start Date ICMJE | July 29, 2022 | ||||
Actual Primary Completion Date | January 8, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
End of dose escalation [ Time Frame: 28 days after TK-8001 treatment of last patient in Phase 1 ] RP2D will be determined through integrated evaluation of adverse events, serious adverse events, antitumoral activity, and evaluation of the biological and physiological effects of TK-8001 in the body.
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Original Secondary Outcome Measures ICMJE |
End of dose escalation [ Time Frame: 28 days after TK-8001 treatment of last patient in part 1 ] RP2D will be determined through integrated evaluation of adverse events, serious adverse events, antitumoral activity, and evaluation of the biological and physiological effects of TK-8001 in the body.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | 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 Not Eligible for Them or Are in a Non- Curable State and Have Received a Minimum of Two Lines of Systemic Therapy | ||||
Brief 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. | ||||
Detailed Description | This is 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 subjects with HLA-A*02:01 genotype and advanced stage/metastatic, MAGE-A1+ solid tumors (including but not limited to melanoma [skin or uveal], NSCLC, urothelial, breast, gastric [including gastroesophageal junction], esophageal, sarcoma, HNSCC, HCC, biliary tract, cervical, and salivary gland cancer) that either have no further approved therapeutic alternative or are not eligible for them or that are in a non-curable state as per the Investigator's assessment and have received a minimum of two lines of systemic therapy. This two-part clinical trial will consist of a Phase 1 Part, which includes dose-escalation and expansion, and a Phase 2 Part. In the Phase 1 Part dose-escalation, at least 6 subjects and up to 18 subjects (if DLT occurs) will receive escalating doses of TK-8001, with up to three dose levels explored. During the Phase 1 Part expansion, up to 20 additional subjects may be treated on DL3 if cleared during dose escalation to further evaluate the safety and efficacy of TK-8001 (Cohort 1). An additional cohort of up to 10 subjects with brain metastases (Cohort 2) may also be treated on DL3 if cleared during dose-escalation. The maximum total number of subjects to be treated on DL3 during Phase 1 will be 33 subjects. In the Phase 2 Part, 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 and Phase 2 Part of the trial will consist of the following periods: Screening and Leukapheresis Period, Conditioning Period, TK-8001 Treatment Period, DLT Monitoring Period, Short-term Follow-up Period (Year 1), and Long-term Follow-up Period (Year 2 - 15). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: This 2-part trial consists of Phase 1 dose-escalation and expansion and Phase 2. In escalation, 6-18 subjects will receive TK-8001 across 3 dose levels (DL). In expansion, subjects will be treated with the DL selected in escalation. Subjects without brain metastasis (Cohort 1) and subjects with brain metastases (Cohort 2) will both be included in expansion if DL3 is declared safe. Cohort 1 will include melanoma [skin or uveal], NSCLC, urothelial, breast, gastric esophageal, sarcoma, HNSCC, HCC, biliary tract, cervical, and salivary gland cancer subjects. Cohort 2 will only include melanoma [skin or uveal], NSCLC, urothelial, or breast cancer. In expansion, up to 20 additional subjects may be treated on DL3 if cleared during escalation. Up to 10 additional Cohort 2 subjects may be treated on DL3 if cleared during escalation. 33 subjects maximum may be treated on DL3 during Phase 1. If DL2 was safely completed the maximum total number of subjects to be treated on DL2 would be 12. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumors | ||||
Intervention ICMJE | Biological: Autologous CD8+ T-cells, transduced with MAGE-A1 directed TCR
Single-dose intravenous infusion of MAGE-A1 directed TCR-transgenic T cells following a conditioning chemotherapy
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Study Arms ICMJE | Experimental: MAGE-A1 - directed TCR transduced autologous T-cells
Single-dose, intravenous infusion
Intervention: Biological: Autologous CD8+ T-cells, transduced with MAGE-A1 directed TCR
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
23 | ||||
Original Estimated Enrollment ICMJE |
48 | ||||
Actual Study Completion Date ICMJE | January 8, 2024 | ||||
Actual Primary Completion Date | January 8, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium, Germany, Netherlands, Spain, United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05430555 | ||||
Other Study ID Numbers ICMJE | TK-8001-01 2021-004158-49 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | T-knife GmbH | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | T-knife GmbH | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | T-knife GmbH | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |