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Trial Title:
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
NCT ID:
NCT06617000
Condition:
HCC
Hepatitis B Virus Related Hepatocellular Carcinoma
Hepatocellular Carcinoma
Conditions: Official terms:
Hepatitis A
Hepatitis B
Carcinoma
Carcinoma, Hepatocellular
Hepatitis
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SCG101
Description:
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Arm group label:
SCG101
Summary:
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy
of SCG101 monotherapy for patients with HBV-HCC.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing
Address:
City:
Beijing
Zip:
100020
Country:
China
Status:
Recruiting
Facility:
Name:
Guangzhou
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Facility:
Name:
Zhengzhou
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Facility:
Name:
Changchun
Address:
City:
Chang chun
Zip:
130000
Country:
China
Status:
Recruiting
Facility:
Name:
Shenyang
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Facility:
Name:
Ji'nan
Address:
City:
Ji'nan
Zip:
250000
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Start date:
October 25, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
SCG Cell Therapy Pte. Ltd.
Agency class:
Industry
Source:
SCG Cell Therapy Pte. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06617000
