Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC

April 2, 2024 updated by: OriCell Therapeutics Co., Ltd.

A Phase Ib/II, Open-Label, Multi-Center Study to Investigate the Safety, PK, and Efficacy of Ori-C101 in Advanced Hepatocellular Carcinoma (HCC) Patients (BEACON)

This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
          • Jian Zhou, MD
        • Contact:
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking university cancer hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
      • Lishui, Zhejiang, China
        • Recruiting
        • Lishui Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed pathologic or radiologic diagnosis of HCC ;
  2. Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
  3. Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
  4. Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
  5. Child-Pugh A or B7, no history of hepatic encephalopathy;
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
  7. Estimated life expectancy of minimum of 12 weeks;
  8. Must have at least 1 target lesion

Exclusion Criteria:

  1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
  2. Prior bone marrow or organ transplantation;
  3. Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
  4. Active hepatitis B infection (If Hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody [HBcAb] positive, then HBV-DNA must be < 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);
  5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
  6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
  7. Inadequate bone marrow reserve or organ function;
  8. History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.
  9. Pregnant or Breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ori-C101 ( GPC3-directed chimeric antigen receptor modified T cells )
Biological: Ori-C101
Hepatic arterial infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose of Ori-C101
Time Frame: 1 year
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 2 years
Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OriCell Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ori-C101-P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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