A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Part of paid clinical trials in New York, New York.

Sponsor
SCG Cell Therapy Pte. Ltd.
Study ID
NCT05417932
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hepatitis B Virus Related Hepatocellular Carcinoma
  • Hepatocellular Carcinoma Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SCG101 — BIOLOGICAL
    Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

Study Details

This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

Key Dates

Start date
Oct 26, 2022
Status verified
Feb 2025
Primary completion
Sep 30, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SCG101
    This is a single arm study. Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.

Primary Outcome Measure

Safety and tolerability of SCG101 [ Time Frame: Start of SCG101 infusion until 100 days post SCG101 infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New YorkNew YorkNew York10029-
New YorkNew YorkNew York10065-

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By research site
New York· New York, NY

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