A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (TCR-T)

SCG Cell Therapy

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma Recurrent; Hepatitis B Virus Related Hepatocellular Carcinoma

Treatments: Biological: SCG101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05417932

SCG101-UR-103

Details and patient eligibility

About

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

Full description

This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels.

In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• 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

Main Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

SCG101

Experimental group

Description:

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.

Treatment:

Biological: SCG101