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A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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)

NCT05623982•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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;
+10 more criteria

Locations (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Harbin First Hospital

Haerbin, Heilongjing, China

Qingdao Central Hospital

Qingdao, Shandong, China

Key Dates

Start Date

September 26, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

September 29, 2025

Enrollment

ESTIMATED participants

Conditions

Non-hodgkin's Lymphoma

Interventions

GNC-038

DRUG

Contacts

Sa Xiao, PHD

CONTACT

+86-15013238943 xiaosa@baili-pharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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