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

NCT05623982 | Recruiting Phase 1

• 1 other identifier: GNC-038-104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Conditions

Non-hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)

  The incidence and severity of adverse events (TEAE) during treatment were graded according to the National Cancer Institute Standard for Common Terminology for Adverse Events (NCI-CTCAE, v5.0).

  Up to 14 days after the first dose

• Maximum tolerated dose (MTD) or Maximum dose (MAD)

  In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.

  Up to 14 days after the first dose

• Adverse Events during Treatment (TEAE)

  TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-038. The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-038.

  Up to approximately 24 months

• Recommended dose for Phase II clinical studies (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-038.

  Up to 14 days after the first dose

Secondary Outcomes (10)

• disease control rate (DCR)

  Up to approximately 24 months

• progression-free survival (PFS)

  Up to approximately 24 months

• Adverse Events of Special Interest (AESI)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

• Tmax

  Up to approximately 24 months

Other Outcomes (4)

• Neutralizing antibody (Nab) in phase Ⅰb

  Up to approximately 24 months

• Overall survival (OS) in phaseⅠb and phase Ⅱ

  Up to approximately 24 months

• Neutralizing antibody (Nab) in phaseⅡ

  Up to approximately 24 months

Study Arms (1)

Study treatment

EXPERIMENTAL

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.

Drug: GNC-038

Interventions

GNC-038 DRUG

Administration by intravenous infusion

Study treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form;
• No gender restrictions;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with histologically confirmed non-Hodgkin's lymphoma;
• Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL);
• 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);
• ECOG performance status score ≤2;
• Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria;
• Organ function levels meet the requirements before the first dose;
• 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;
• The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

You may not qualify if:

• Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);
• Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
• Active tuberculosis;
• Patients with active autoimmune diseases;
• History of other malignancies within 5 years prior to the first dose;
• 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;
• Poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg);
• History of severe cardiovascular or cerebrovascular diseases;
• Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038;
• Pregnant or lactating women;
• Patients with central nervous system involvement;
• Major surgery within 28 days before the first dose of this study or planned major surgery during the study period;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment;
• Current use of immunosuppressive therapy;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• SystImmune Inc.: collaborator
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Harbin First Hospital

Haerbin, Heilongjing, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jun Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Yuqin Song

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86-15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: November 21, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)