A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
NCT ID: NCT06617000
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
38 participants
INTERVENTIONAL
2022-10-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SCG101
SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Interventions
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SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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SCG Cell Therapy Pte. Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing
Beijing, Beijing Municipality, China
Guangzhou
Guangzhou, Guangdong, China
Zhengzhou
Zhengzhou, Henan, China
Changchun
Changchun, Jilin, China
Shenyang
Shenyang, Liaoning, China
Ji'nan
Ji'nan, Shandong, China
Shanghai
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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SCG-101-CR-102
Identifier Type: -
Identifier Source: org_study_id