TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Intervencionista
Fase 1/2
Singapore
Patrocinador: SCG Cell Therapy Pte. Ltd.
Última actualización: 25 de marzo de 2025 Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
* Subjects with HCC who have received at least 2 standard systemic therapies
* HLA-A *02
* BCLC stage B or C
* Child-pugh score ≤ 7
* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
* Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
* Life expectancy of 3 months or greater
* Ability to provide informed consent form
* Ability to comply with all the study procedures
Criterios de exclusión
* Subjects with history of another primary cancer
* Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
* Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
* Known history of neurological or mental disorder, including epilepsy or dementia
* Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T/TCR T cell therapy
* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
* Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
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Detalles del diseño
AsignaciónN/A
Modelo de intervenciónSingle Group Assignment
EnmascaramientoNone (Open Label)
Número a inscribir46
Brazos e Intervenciones
Brazos
Intervenciones
Tipo: Experimental
Descripción: This is a single arm study.
Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.
Intervenciones:
SCG101
Medidas de resultado
Medidas de resultado primarias
Safety and tolerability of SCG101Start of SCG101 infusion until 100 days post SCG101 infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Tumor response of SCG101 (Phase 2)Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
Medidas de resultado secundarias
Preliminary clinical efficacy of SCG101Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Objective response rate
Antiviral activity before and after SCG101 infusionStart of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Based on changes in serum levels of HBsAg
Change in pharmacodynamic markers (PD) before and after SCG101 infusionStart of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Based on changes in serum from the liver function
Persistence of viral vector copy number (VCN) after SCG101 infusionStart of SCG101 infusion until disease progression, an average of 24 months.
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