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

NCT ID: NCT05623982

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2027-12-31

Brief 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

Detailed 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

Conditions

Non-hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study treatment

Participants receive GNC-038 as intravenous infusion for the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Group Type: EXPERIMENTAL

GNC-038

Intervention Type: DRUG

Administration by intravenous infusion

Interventions

GNC-038

Administration by intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject is capable of understanding the informed consent form, voluntarily participates, 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 with any 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 per CTCAE 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 of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;

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

Exclusion Criteria

1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently 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 of detection; 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 blood pressure >100 mmHg);

8. History of severe cardiovascular or cerebrovascular diseases;

9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any 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 major surgery 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 weeks before 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 prior to 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 5 half-lives before the first dose of this study;

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SystImmune Inc.

INDUSTRY

Sponsor Role: collaborator

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Zhu

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Yuqin Song

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Harbin First Hospital

Haerbin, Heilongjing, China

Site Status: RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sa Xiao, PHD

Role: CONTACT

xiaosa@baili-pharm.com

+86-15013238943

Facility Contacts

Jun Zhu

Role: primary

zhujun3346@163.com

010-88196115

Yuqin Song

Role: backup

SongYQ_VIP@163.com

010-88196118

Zhiguo Wang

Role: primary

Ling Wang

Role: primary

Other Identifiers

GNC-038-104

Identifier Type: -

Identifier Source: org_study_id