RecruitingPhase 1NCT07073833

The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma

An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IBR900 Cell Injection in the Treatment of Relapsed/Refractory CD20 Positive B-cell Non Hodgkin Lymphoma


Sponsor

Imbioray (Hangzhou) Biomedicine Co., Ltd.

Enrollment

40 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided into two parts: monotherapy expansion (queue 1) and combination expansion (queue 2). The monotherapy expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma, while the combination expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection combined with CD20 monoclonal antibodies in the treatment of relapsed/refractory CD20 positive B-cell non Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and effectiveness of a new type of immune cell therapy called IBR900 in people with a type of blood cancer called B-cell non-Hodgkin's lymphoma that has come back or is not responding to standard treatments. **You may be eligible if...** - You are 18 years or older - You have a confirmed diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma (including diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, and others) - Your cancer has come back or stopped responding to treatment that included rituximab or another CD20-targeting drug and an anthracycline-type chemotherapy - You are in reasonably good health and your major organs are functioning adequately **You may NOT be eligible if...** - Your cancer has never been treated with the required prior therapies - Your overall health is too poor to safely receive this therapy - You have conditions that would make you ineligible based on the study's safety criteria 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

DRUGIBR900 cell injection

NK cells

DRUGrituximab

CD20 antibody


Locations(2)

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Shanghai Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07073833


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