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RECRUITING
NCT07724756
PHASE2

Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

QLC2519 (Mai Li Sheng®) is a new protein drug created by fusing the N-terminal of highly active modified G-CSF with the C-terminal of HSA. The modified G-CSF retained high activity while reducing affinity for the G-CSF receptor, which can significantly inhibit the the G-CSF receptor-mediated (RMC) pathway. The aim of this study is to evaluate the PK/PD characteristics of QLC2519 in preventing chemotherapy-induced neutropenia (CIN) in children with sarcoma.

Official title: A Multicenter, Open-label Phase II Clinical Study Evaluating the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Albipagrastim Alfa for Injection (QLC2519) in Pediatric Solid Tumor Participants

Key Details

Gender

All

Age Range

0 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-06-26

Completion Date

2028-06-26

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

Albipagrastim alf

QLC2519 500 μg/kg was administered 48 hours after chemotherapy (generally on D4 of the first and third chemotherapy cycles, and on D7 of the second cycle, between 6:00 and 10:00 AM), once per chemotherapy cycle.

Locations (1)

Beijing Children's Hospital

Beijing, China