RecruitingPhase 1Phase 2NCT05623982

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

An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

40 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin's Lymphoma

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

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.

Exclusion Criteria20

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;
Radiotherapy within 4 weeks before initiating GNC-038 treatment;
Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment;
CAR-T therapy within 12 weeks before initiating GNC-038 treatment;
Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study;
Any other condition deemed unsuitable for participation in this clinical trial by the investigator.