Clinical trial NCT05417932: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Official title: A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hepatitis B Virus Related Hepatocellular Carcinoma
Hepatocellular Carcinoma Recurrent
Keywords: HCC
Hepatitis B Virus Related
HCC Recurrent
Lead sponsor: SCG Cell Therapy Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability of SCG101
timeFrame: Start of SCG101 infusion until 100 days post SCG101 infusion
measure: Tumor response of SCG101 (Phase 2)
timeFrame: 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
Secondary outcomes:
measure: Preliminary clinical efficacy of SCG101
timeFrame: Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
measure: Antiviral activity before and after SCG101 infusion
timeFrame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
measure: Change in pharmacodynamic markers (PD) before and after SCG101 infusion
timeFrame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
measure: Persistence of viral vector copy number (VCN) after SCG101 infusion
timeFrame: Start of SCG101 infusion until disease progression, an average of 24 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Hong Kong
country: Hong Kong
facility: Hong Kong is.
city: Hong Kong
country: Hong Kong
facility: Hong Kong NT
city: Singapore
country: Singapore
facility: Singapore
city: Singapore
country: Singapore
facility: Singapore
Study officials:
affiliation: SCG Cell Therapy Pte. Ltd.
name: SCG Cell Therapeutics
role: STUDY_DIRECTOR
References: