A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Last updated: September 26, 2025
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Non-hodgkin's Lymphoma

Cancer/tumors

Treatment

GNC-038

Clinical Study ID

NCT05623982
GNC-038-104
  • Ages 18-75
  • All Genders

Study Summary

To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subject is capable of understanding the informed consent form, voluntarilyparticipates, and signs the informed consent form;

  2. No gender restrictions;

  3. Age: ≥18 years and ≤75 years;

  4. Expected survival time ≥3 months;

  5. Patients with histologically confirmed non-Hodgkin's lymphoma;

  6. Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL);

  7. Presence of measurable lesions during the screening period (lymph node lesions withany long diameter ≥1.5 cm or extranodal lesions with any long diameter >1.0 cm);

  8. ECOG performance status score ≤2;

  9. Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as perCTCAE 5.0 criteria;

  10. Organ function levels meet the requirements before the first dose;

  11. Female subjects of childbearing potential or male subjects with partners ofchildbearing potential must use highly effective contraception from 7 days beforethe first dose until 12 weeks after treatment discontinuation. Female subjects ofchildbearing potential must have a negative serum/urine pregnancy test within 7 daysbefore the first dose;

  12. The subject has the ability and willingness to comply with the studyprotocol-specified visits, treatment plans, laboratory tests, and otherstudy-related procedures.

Exclusion

Exclusion Criteria:

  1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patientscurrently diagnosed with interstitial lung disease (ILD);

  2. Active infections requiring systemic treatment, such as severe pneumonia,bacteremia, sepsis, etc.;

  3. Active tuberculosis;

  4. Patients with active autoimmune diseases;

  5. History of other malignancies within 5 years prior to the first dose;

  6. HBsAg-positive and/or HBcAb-positive with HBV-DNA levels ≥ the lower limit ofdetection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection;HIV antibody-positive;

  7. Poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic bloodpressure >100 mmHg);

  8. History of severe cardiovascular or cerebrovascular diseases;

  9. Patients with a history of hypersensitivity to recombinant humanized antibodies orany excipients of GNC-038;

  10. Pregnant or lactating women;

  11. Patients with central nervous system involvement;

  12. Major surgery within 28 days before the first dose of this study or planned majorsurgery during the study period;

  13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);

  14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeksbefore initiating GNC-038 treatment;

  15. Current use of immunosuppressive therapy;

  16. Radiotherapy within 4 weeks before initiating GNC-038 treatment;

  17. Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives priorto treatment;

  18. CAR-T therapy within 12 weeks before initiating GNC-038 treatment;

  19. Use of any other investigational drug in a clinical trial within 4 weeks or 5half-lives before the first dose of this study;

  20. Any other condition deemed unsuitable for participation in this clinical trial bythe investigator.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: GNC-038
Phase: 1/2
Study Start date:
September 26, 2022
Estimated Completion Date:
December 31, 2027

Study Description

phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2 weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed or refractory non-Hodgkin's lymphoma

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Active - Recruiting

  • Harbin First Hospital

    Haerbin, Heilongjing
    China

    Active - Recruiting

  • Qingdao Central Hospital

    Qingdao, Shandong
    China

    Site Not Available

  • Qingdao Central Hospital

    Qingdao 1797929, Shandong 1796328
    China

    Active - Recruiting

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