RecruitingPhase 2

Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

China18 participantsStarted 2026-06-26

Plain-language 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.

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 0-18 years (excluding boundary values), any gender; * Participant diagnosed with pediatric sarcoma based on pathological histology; * Participant was suitable for receiving the VDC/IE chemotherapy regimen, and planning to receive at least 3 chemotherapy cycles (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide); * ECOG ≤1; * Expected survival ≥3 months, and expected to complete the 3 chemotherapy cycles specified in the regimen; * Hematology, liver function, and renal function before the first administration of chemotherapy drugs meet the following requirements: * Hematology: absolute neutrophil count (ANC) in peripheral blood ≥2.0×10\^9/L (or above the lower limit of normal); platelet count (PLT) ≥100×10\^9/L; hemoglobin (HGB) ≥90 g/L; white blood cell count (WBC) ≥4.0×10\^9/L; * Liver function: total bilirubin (TBIL) ≤1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; for patients with liver metastasis, ALT and AST ≤2.5×ULN; * Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr) ≥60 mL/min; * Normal bone marrow hematopoietic function, no bleeding tendency (INR \<1.5); * Female participants of potential reproductive ability (post-menarche) are neither pregnant nor breastfeeding; participants of potential reproductive ability (e.g., females post-menarche or males post-spermarche) must agree to use effective contraception from the time of signing the informed co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cmax of QLC2519

Timeframe: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]

AUC0-t of QLC2519

Timeframe: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]

Time to start administering chemotherapy drugs until the nadir of absolute neutrophil count (ANC)

Timeframe: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]

Trial details

NCT IDNCT07724756

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-26

View on ClinicalTrials.gov More Pediatric Malignant Solid Tumor trials

Plain-language summary

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cmax of QLC2519

Timeframe: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]

AUC0-t of QLC2519

Timeframe: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]

Time to start administering chemotherapy drugs until the nadir of absolute neutrophil count (ANC)

Timeframe: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]