NCT06891742

Phase I Study of OriC902 in Treatment of Advanced HCC

A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, and Initial Efficacy of a GPC3-targeted Chimeric Antigen Receptor Autologous T Cell Injection (OriC902) in GPC3-positive Advanced Hepatocellular Carcinoma (HCC) Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I clinical study evaluating the safety, pharmacokinetics, and initial efficacy of a GPC3-targeted chimeric antigen receptor autologous T cell injection (OriC902) in GPC3-positive advanced hepatocellular carcinoma (HCC) subjects

Detailed description

The study consists of two phases: dose escalation phase and extension phase. "Accelerated titration" and "traditional 3+3 design" were used for dose escalation in the dose escalation stage. In this study, "accelerated titration" was planned for dose escalation in the low-dose phase (1.0E6/Kg and 3.0E6/ Kg). Starting from the dose group of 6.0E6/Kg, dose escalation was carried out using the "traditional 3+3 design" rule. After the DLT observation and PK analysis of all subjects in each dose group is completed, the investigator will determine whether to increase to the next dose group based on the safety, efficacy (if any) and PK data obtained previously. A Safety Review Committee (SRC) meeting may be convened during the trial if DLT or special conditions in one dose group are found to warrant discussion by the investigator. The SRC will discuss and make decisions on the next dose group dose, maximum tolerated dose (MTD), different routes of administration (e.g., hepatic arterial perfusion, intravenous infusion), extended recommended dose (RDE), and dose grouping based on safety, initial efficacy (if any), and PK data. After the maximum tolerated dose (MTD) and extended recommended dose (RDE) have been determined, the dose extension phase will continue to observe at least 10 subjects in each dose group within the defined 1-2 extended recommended doses to further observe safety and antitumor activity.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	OriC902	Whole peripheral blood mononuclear cells are extracted from patients (or donors) through leukocyte separation, and then the required T cell subsets are isolated, which will become the basis for the subsequent preparation of CAR T cells

Timeline

• Start date: 2025-02-24
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

2 sites across 1 country: China