RecruitingPhase 1Phase 2NCT06021678

Safety and Efficacy of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

A Phase I/II Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma


Sponsor

Guangzhou Excelmab Inc.

Enrollment

415 participants

Start Date

Nov 12, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests EX103, a new antibody drug targeting CD20, in people with B-cell non-Hodgkin lymphoma (a type of blood cancer) that has relapsed or stopped responding after at least 2 prior treatment regimens. **You may be eligible if...** - You are 18 or older with CD20-positive non-Hodgkin lymphoma confirmed at initial diagnosis - Your lymphoma has relapsed or not responded after at least 2 prior lines of treatment - No suitable treatment options are available - For the expansion phase: you may have DLBCL, follicular lymphoma, or other CD20-positive NHL subtypes depending on the cohort **You may NOT be eligible if...** - Your cancer has lost CD20 expression after prior rituximab treatment - You have uncontrolled serious infections (HIV, active hepatitis B or C) - You are pregnant or breastfeeding - You have a known allergy to the study drug - You have active CNS lymphoma 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

DRUGEX103 injection

Administered as specified in the treatment arm.


Locations(4)

Cancer Hospital Affiliated to Zhengzhou University, Henan Cancer Hospital

Zhengzhou, Henan, China

Qilu Hospital, Cheeloo College of Medicine, Shandong University

Jinan, Shandong, China

Shanghai Sixth People's Hospital, Shanghai Jiaotong University school of Medicine

Shanghai, Shanghai Municipality, China

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06021678