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COMPLETED
NCT07845266
PHASE1

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GKL-006 Injection in Combination With TACE in Unresectable Hepatocellular Carcinoma

Sponsor: Beijing Gene Key Life Technology Co., Ltd

View on ClinicalTrials.gov

Summary

This Phase Ia study evaluated the safety and tolerability of a single escalating dose via intravenous infusion of the autologous invariant natural killer T cells (iNKT-cell) product GKL-006 in combination with transarterial chemoembolisation (TACE) in participants with unresectable hepatocellular carcinoma (uHCC). The study aimed to characterise dose-limiting toxicities (DLT), determine the maximum tolerated dose (MTD), and assess pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumour activity.

Official title: A Phase 1, Open-label, Controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2024-04-16

Completion Date

2025-12-04

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

GKL-006 Injection

Autologous iNKT cells collected and reinfused after in vitro cultivation.

DRUG

transarterial chemoembolization

A standard locoregional therapy for hepatocellular carcinoma.

Locations (2)

Beijing Ditan Hospital Chaoyang Campus

Beijing, Beijing Municipality, China

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, China