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

Hepatocellular Carcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652920
• Other study ID #: Ori-C101-P1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 15, 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: OriCell Therapeutics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• Ori-C101
Hepatic arterial infusion

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing
China	The first hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital	Chengdu	Sichuan
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Lishui Central Hospital	Lishui	Zhejiang
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
OriCell Therapeutics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate	Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria.	2 years