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Pediatric Malignant Solid TumorPhase 2NCT07724756

Phase II Study of QLC2519 in Pediatric Solid Tumor Participants

A Phase 2 study testing Albipagrastim alf in people with Pediatric Malignant Solid Tumor and Febrile Neutropenia (FN), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 to 18 years
What is being tested?
Albipagrastim alf
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
26 Jun 2026to 26 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Received whole blood, white blood cells, or platelet transfusion within 2 weeks prior to screening;
  • Received human granulocyte colony-stimulating factor (G-CSF) treatment within 3 months prior to screening;
  • Received systemic anti-infective therapy (oral or intravenous) within 72 hours prior to screening;
  • History of drug or alcohol abuse, or history of substance abuse;
  • Received other clinical trial drugs or treatments within 4 weeks prior to screening;
  • History of allergic diseases, being of an allergic constitution, or known allergy to any drug or component of this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Beijing Children's Hospital

    Beijing

    Beijing Children's Hospital Beijing Children's Hospital, 01058531216, bcec_ist@bch.com.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

This study is a multicenter, open lable Phase II study planed to enroll 18 children with pediatric sarcoma. The participants will receive the VDC/IE chemotherapy regimen (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide) and will be scheduled to undergo 3 chemotherapy cycles (21 days per cycle). The participants will be stratified by age (<6 years, 6 to <12 years, 12 to <18 years), with enrollment progressing from the older to the younger age groups (6 in each group).

Being tested
Albipagrastim alf
Keywords
Pediatric Malignant Solid Tumor, Children, Albipagrastim alfa for Injection, neutropenia, Febrile neutropenia (FN)
Medical subject headings
Febrile Neutropenia, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albipagrastim alfDrug

    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.

Study groups in NCT07724756
Study groupRoleWhat they receive
Treatment GroupExperimentalChemotherapy 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.
Receives: Drug: Albipagrastim alf

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of QLC2519

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

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

  2. AUC0-t of QLC2519

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

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

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

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

Secondary outcomes (4)

  1. Duration and incidence of severe ANC reduction

    ANC < 0.5 × 10⁹/L

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

  2. Efficacy: Incidence of febrile neutropenia (FN)

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

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

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

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

    Measured: Up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study start26 Jun 2026 (estimated)
  3. Primary completion26 Jun 2027 (estimated)
  4. Study completion26 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07724756
Sponsor's protocol ID
QLC2519-201
Status last verified
Jul 2026
First submitted
29 Jun 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Albipagrastim alf in people with Pediatric Malignant Solid Tumor and Febrile Neutropenia (FN), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of QLC2519 (time frame: At treatment Cycle 1 and Cycle 3 (cycle length = 21 days)]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07724756.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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