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

Last updated: September 25, 2024
Sponsor: SCG Cell Therapy Pte. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Liver Disorders

Digestive System Neoplasms

Treatment

SCG101

Clinical Study ID

NCT06617000
SCG-101-CR-102
  • Ages 18-70
  • All Genders

Study 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

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 mustbe ≤ 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

Exclusion Criteria:

  • Subjects with history of another primary cancer within 5 years

  • Central nervous system metastasis and clinically significant central nervous systemdisease

  • 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., arterialhypertension 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 immunerejection 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 IgMantibody; or there is current evidence indicating the presence of HEV infection

  • Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamideand fludarabine)

  • Any condition which, in the investigator's opinion, makes the subject unsuitable fortrial participation

Study Design

Total Participants: 38
Treatment Group(s): 1
Primary Treatment: SCG101
Phase: 1
Study Start date:
October 25, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Beijing

    Beijing, Beijing 100020
    China

    Active - Recruiting

  • Guangzhou

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Zhengzhou

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Changchun

    Chang chun, Jilin 130000
    China

    Active - Recruiting

  • Shenyang

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Ji'nan

    Ji'nan, Shandong 250000
    China

    Active - Recruiting

  • Shanghai

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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