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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called GNC-038 for people with non-Hodgkin's lymphoma — a type of blood cancer — whose disease has come back or stopped responding to prior treatments. GNC-038 is a bispecific antibody designed to help the immune system attack lymphoma cells. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed non-Hodgkin's lymphoma that has relapsed or is no longer responding to prior treatments - You have measurable lymphoma visible on imaging - Your cancer does not involve the brain or spinal cord - You are generally active and able to perform self-care **You may NOT be eligible if...** - You have active lung disease, interstitial lung disease, or a serious infection - You have active hepatitis B, hepatitis C, or HIV - You have had another cancer in the past 5 years - You have had a prior organ transplant or bone marrow transplant from a donor - You have had CAR-T therapy in the past 12 weeks - You have poorly controlled high blood pressure or a history of serious heart or stroke events - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGNC-038

Administration by intravenous infusion


Locations(3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Harbin First Hospital

Haerbin, Heilongjing, China

Qingdao Central Hospital

Qingdao, Shandong, China

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NCT05623982


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