Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

NCT07724756 | Recruiting Phase 2 DMC

• 1 other identifier: QLC2519-201
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Malignant Solid Tumor; Children; Albipagrastim alfa for Injection; neutropenia; Febrile neutropenia (FN)

Outcome Measures

Primary Outcomes (3)

• Cmax of QLC2519

  Maximum (peak) serum concentration (Cmax) of QLC2519 will be reported.

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

• AUC0-t of QLC2519

  Area Under the Curve from time zero to time t (AUC0-t) of QLC2519 will be reported.

  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)

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

Secondary Outcomes (4)

• Duration and incidence of severe ANC reduction

  At treatment cycle 1 to cycle 3 (cycle length = 21 days)

• Efficacy: Incidence of febrile neutropenia (FN)

  At treatment cycle 1 to cycle 3 (cycle length = 21 days)

• Duration and incidence of ANC < 1.0 × 10^9/L

  At treatment cycle 1 to cycle 3 (cycle length = 21 days)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Week 14

Study Arms (1)

Treatment Group

EXPERIMENTAL

Chemotherapy C1\&3: Changchun Shinkai (V): 1.5 mg/m² (maximum dose 2 mg), iv, on D1, 8, and 15; Doxorubicin (D): 30 mg/m², iv over more than 6 hours, on D1 and 2; Cyclophosphamide (C): 1.2 g/m², iv over more than 1 hour, on D1; Mesna: 360 mg/(m²/dose), iv, at 0, 3, 6, and 9 hours during cyclophosphamide. Chemotherapy C2: Ifosfamide (I): 1.8 g/m², iv over more than 1 hour, QD for 5 days (D1\~D5); Etoposide (E): 100 mg/m², iv over more than 4 hours, QD for 5 days (D1\~D5); Mesna: 360 mg/(m²/dose), iv, at 0, 3, 6, 9 hours during ifosfamide.

Drug: Albipagrastim alf

Interventions

Albipagrastim alf DRUG

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.

Treatment Group

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 consent until at least 3 months after the last administration.

You may not qualify if:

• Tumor had metastasized to or invaded the bone marrow;
• Previously received chemotherapy or radiotherapy;
• Planned surgery or radiotherapy during the trial (excluding the follow-up period);
• Presence of other malignant tumors besides sarcoma (participants with previously cured malignant tumors with no recurrence within the past 5 years may be included in this study);
• Primary central nervous system tumor or existing central nervous system involvement, or suspected central nervous system metastasis based on clinical manifestations, deemed unsuitable for participation in this study by the investigator;
• History of primary hematologic diseases, including but not limited to leukemia, myelodysplastic syndromes, aplastic anemia, sickle cell anemia, congenital neutropenia, or cyclic neutropenia;
• Previously received or planned to undergo bone marrow transplantation, hematopoietic stem cell transplantation, or organ transplantation during the trial;
• Diseases with severe cardiac dysfunction, including but not limited to poorly controlled arrhythmia or heart failure;
• Diseases with severe pulmonary dysfunction, including but not limited to pulmonary embolism, lung abscess, or acute respiratory distress syndrome;
• Presence of splenomegaly or diseases that may cause splenomegaly (such as liver cirrhosis, Gaucher disease, glycogen storage disease, Niemann-Pick disease, etc.), considered unsuitable for participation in this study by the investigator;
• Presence of acute infectious disease or chronic infectious disease in the active phase at screening, such as hepatitis B patients who are hepatitis B surface antigen (HbsAg) positive with detectable HBV-DNA indicating viral replication, hepatitis C patients who are anti-HCV antibody positive with detectable HCV-RNA indicating viral replication; positive syphilis screening (positive specific antibody test, negative nonspecific antibody test, and confirmed as non-active infection based on clinical judgment is excluded);
• History of human immunodeficiency virus (HIV) infection, or HIV positive at screening;
• Undergoing major surgery within 1 month prior to screening (high-risk, complex, or difficult procedures, such as thoracoscopic pulmonary bulla resection or thoracoscopic esophageal atresia surgery);
• Received or planned to use recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) within 1 week prior to screening or during the trial;
• Received glucocorticoid (oral or intravenous) or lithium treatment within 1 week prior to screening;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Children's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Febrile Neutropenia; Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 24, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): June 26, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)