Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC

Официальное название

A Multi-center, Phase 2 Study for Autologous T Cells Transfected With mRNA Encoding HBV Antigen-specific TCR (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for Advanced HBV-related Hepatocellular Carcinoma

Обзор

This is an open-label and multi-center Phase 2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).

Вмешательства

• Биопрепарат LioCyx-M
  HBV antigen specific TCR redirected T cells
• Препарат Lenvatinib
  12 mg once daily for patients ≥60 kg, 8 mg for patients \<60kg by oral

Первичные конечные точки

• Assessments of adverse events/serious adverse events [Срок оценки: Up to 4 years from study treatment initiation]
• Objective response rate (ORR) [Срок оценки: Up to 4 years from study treatment initiation]

Вторичные конечные точки (4)

• Progression free survival (PFS) [Срок оценки: Up to 4 years from study treatment initiation]
• Time to radiographic progression (TTRP) [Срок оценки: Up to 4 years from study treatment initiation]
• Duration of response (DoR) [Срок оценки: Up to 4 years from study treatment initiation]
• Overall survival (OS) [Срок оценки: Up to 4 years from study treatment initiation]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Advanced HCC with diagnosis confirmed by histology/ cytology or clinically by AASLD criteria in cirrhotic patients.
• Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
• Patients who failed first-line systemic therapy for HCC
• Serum HBsAg positivity
• Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
• HLA class 1 profile matching HLA-class I restriction element of the available T cell receptor

Критерии исключения

• Brain metastasis
• Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumours.
• Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
• History of severe allergic anaphylactic reactions to T cell therapy products and/or lenvatinib
• Local or loco-regional therapy of intrahepatic tumour lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks before the first infusion of LioCyx-M.
• Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, tyrosine kinase inhibitor therapy, and immunotherapy.
• Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to first infusion. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis.
• Treatment with other investigational therapy within 28 days prior to initiation of study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
• Likelihood to require any immunosuppressive treatments during the period of the clinical trial (Localized steroid use should be allowed)
• Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for HBV)
• Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina
• Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic pressure >110 mmHg, despite optimal medical management

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05195294 · LTCR-HCC-3-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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