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Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

NCT07724756 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Pediatric Malignant Solid Tumor
  • Febrile Neutropenia (FN)
  • Neutropenia

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2027-06-26
Completion
2028-06-26

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724756 on ClinicalTrials.gov