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)

  • STATUS
    Recruiting
  • End date
    Jun 10, 2037
  • participants needed
    48
  • sponsor
    T-knife GmbH
Updated on 4 October 2022

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 IdentifierNCT05430555
SponsorT-knife GmbH
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to understand and comply with study procedures
At least 18 years old
Advanced-stage/metastatic, solid tumor malignancy with no further available approved therapeutic alternative(s) or in a non-curable state as per treating physician's assessment with the patient having received a minimum of two lines of approved systemic therapy
HLA-A02:01 genotype
MAGE-A1+ tumor positive for MAGE-A1
At least one measurable lesion, that can be accurately measured as per RECIST Version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Life expectancy > 3 months as assessed by the Investigator
Adequate organ function
All toxicities related to prior therapy must have recovered to baseline or Grade ≤ 1 based on CTCAE v5.0
Immune-related adverse events (irAEs) from previous therapies must have recovered to baseline or Grade ≤ 1
Women of non-childbearing potential due to surgical sterilization or menopause
Women of childbearing potential must be using a highly effective method of contraception
Men with female partners of childbearing potential must use highly effective methods of contraception

Exclusion Criteria

Any tumor-directed therapy within 14 days before start of conditioning therapy
Any other MAGE-A1-targeting therapy
Pre-existing arrhythmia, uncontrolled angina pectoris, presently uncontrolled heart failure, or any myocardial infarction/coronary event as well as any thromboembolic event at any time < 6 months prior to screening
Left ventricular ejection fraction (LVEF) < 45% as measured by an echocardiogram
History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (within 6 months prior to screening)
Active allergy requiring continuous systemic medication or active infections requiring IV/PO anti-infectious therapy
History of or clinical evidence of CNS primary tumors or metastases
Systemic steroids at a daily dose of > 5 mg of prednisolone, for the last 14 days prior to leukapheresis
Major surgery within last 4 weeks prior to consent
Known/expected hypersensitivity against TK-8001, DMSO, and/or other cellular therapy components
Active disease/ongoing infection with HIV, HBV, HCV, TB, syphilis, or SARS-CoV-2
Any other diseases, or condition that in the opinion of the Investigator would contraindicate the use of the investigational product
Receipt of any organ transplantation, except for transplants that do not require immunosuppression
Any vaccine administration within 4 weeks of IP administration
Patient is pregnant or breastfeeding
Known active drug or alcohol abuse
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