Clinical trial NCT06617000: A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Official title: A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: HCC
Hepatitis B Virus Related Hepatocellular Carcinoma
Hepatocellular Carcinoma
Lead sponsor: SCG Cell Therapy Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 38
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
Primary purpose: TREATMENT

Brief summary: This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
* Subjects with HCC who have received standard systemic therapies
* HLA-A \*02
* BCLC stage B or C
* Child-pugh score ≤ 7 ol
* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
* Have at least one measurable leasion at baseline as per mRECIST and iRECIST
* Life expectancy of 3 months or greater
* The organ function is in good condition.

Exclusion Criteria:

* Subjects with history of another primary cancer within 5 years
* Central nervous system metastasis and clinically significant central nervous system disease
* Previous or current coexistence of hepatic encephalopathy
* Currently present with symptomatic third space fluid accumulation
* Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
* Known history of neurological or mental disorder, including epilepsy or dementia
* Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
* 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
* Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
timeFrame: Start of SCG101 infusion until disease progression or 12 months post infusion
measure: The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
timeFrame: Start of SCG101 infusion until disease progression or 12 months post infusion
measure: Change in pharmacodynamics markers (PD) before and after SCG101 infusion
timeFrame: Start of SCG101 infusion until disease progression, an average of 24 months
measure: Persistences of viral vector copy number (VCN) after SCG101 infusion
timeFrame: Start of SCG101 infusion until disease progression, an average of 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou
state: Guangdong
city: Zhengzhou
country: China
facility: Zhengzhou
state: Henan
city: Chang chun
country: China
facility: Changchun
state: Jilin
city: Shenyang
country: China
facility: Shenyang
state: Liaoning
city: Ji'nan
country: China
facility: Ji'nan
state: Shandong
city: Shanghai
country: China
facility: Shanghai
state: Shanghai
Study officials:
References: