Search / Trial NCT06617000

A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

Launched by SCG CELL THERAPY PTE. LTD. · Sep 25, 2024

Trial Information

Current as of October 04, 2024

Recruiting

Keywords

Description

No description provided

Gender

ALL

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Shanghai, , China

Beijing, Beijing, China

Guangzhou, Guangdong, China

Zhengzhou, Henan, China

Chang Chun, Jilin, China

Shenyang, Liaoning, China

Ji'nan, Shandong, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0