RecruitingPhase 1Phase 2NCT06066203

A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies

An Open, Multicenter, Phase I / II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics / Pharmacodynamics and Antitumor Activity of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

40 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Phase I main objectives: To observe the safety and preliminary efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies, to determine the DLT and MTD, or MAD, and to determine RP2D. Phase II Main objective: To explore the efficacy of GNC-035 in patients with relapsed/refractory non-Hodgkin lymphoma and other hematological malignancies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called GNC-035 for patients with relapsed or refractory non-Hodgkin's lymphoma (a type of blood cancer) and other blood cancers that have stopped responding to prior treatments. **You may be eligible if...** - You are 18–75 years old - You have a confirmed diagnosis of relapsed or refractory non-Hodgkin's lymphoma - You have already tried at least one standard treatment and it stopped working - Your cancer has at least one measurable tumor according to standard criteria (Lugano) - Your general health is adequate (ECOG performance status 0–2) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You are younger than 18 or older than 75 - Your cancer has not been previously treated - You do not have measurable disease on imaging - Your organ function is significantly impaired 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-035

GNC-035 was administered by intravenous infusion for 2 h-4 h, once a week ( IV, QW ), 3 weeks as a cycle.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06066203


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