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

NCT05652920 | Recruiting Phase 1

• 1 other identifier: Ori-C101-P1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 7

Brief Summary

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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of Ori-C101

  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 Outcomes (1)

• Objective Response Rate

  2 years

Study Arms (1)

Ori-C101 ( GPC3-directed chimeric antigen receptor modified T cells )

EXPERIMENTAL

Biological: Ori-C101

Interventions

Ori-C101 BIOLOGICAL

Hepatic arterial infusion

Ori-C101 ( GPC3-directed chimeric antigen receptor modified T cells )

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed pathologic or radiologic diagnosis of HCC ;
• 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;
• 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;
• 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;
• Child-Pugh A or B7, no history of hepatic encephalopathy;
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
• Estimated life expectancy of minimum of 12 weeks;
• Must have at least 1 target lesion

You may not qualify if:

• Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
• Prior bone marrow or organ transplantation;
• 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;
• 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);
• Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
• Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
• Inadequate bone marrow reserve or organ function;
• 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.
• Pregnant or Breast-feeding women.

Sponsors & Collaborators

• OriCell Therapeutics Co., Ltd.: lead

Study Sites (7)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

The first hospital of Jilin University

Changchun, Jilin, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 15, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)