Actively Recruiting
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Led by SCG Cell Therapy Pte. Ltd. · Updated on 2024-09-27
38
Participants Needed
7
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
CONDITIONS
Official Title
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received standard systemic therapies
- HLA-A *02 positive
- BCLC stage B or C
- Child-Pugh score of 7 or less
- Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA 4 1000 IU/ml
- At least one measurable lesion at baseline according to mRECIST and iRECIST
- Life expectancy of 3 months or greater
- Organ function in good condition
You will not qualify if you...
- History of another primary cancer within 5 years
- Central nervous system metastasis or clinically significant CNS disease
- Previous or current hepatic encephalopathy
- Presence of symptomatic third space fluid accumulation
- Poorly controlled hypertension despite treatment
- Known neurological or mental disorders including epilepsy or dementia
- Active autoimmune diseases or ongoing immune rejection
- Prior exposure to any cell therapy such as NK cells, CIK cells, dendritic cells, CTL, or stem cell therapy
- Positive test for HCV RNA, HAV IgM antibody, HDV IgM antibody, or evidence of HEV infection
- Allergy to immunotherapy drugs or lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- Any condition making the subject unsuitable for trial participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Beijing
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
2
Guangzhou
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Zhengzhou
Zhengzhou, Henan, China, 450003
Actively Recruiting
4
Changchun
Changchun, Jilin, China, 130000
Actively Recruiting
5
Shenyang
Shenyang, Liaoning, China, 110000
Actively Recruiting
6
Ji'nan
Ji'nan, Shandong, China, 250000
Actively Recruiting
7
Shanghai
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
S
SCG Cell Therapy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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