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)

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Advanced stage solid tumors, MAGE-A1, TCR-transgenic T-cells Read More

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-A*02:01 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