RecruitingPhase 2NCT07724756

Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

18 participants

Start Date

Jun 26, 2026

Study Type

INTERVENTIONAL

Conditions

Neutropenia Febrile Neutropenia (FN)Pediatric Malignant Solid Tumor

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.

Eligibility

Min Age: 0 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Albipagrastim alf for people with febrile neutropenia (fn), neutropenia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlbipagrastim 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.