drugset / Trial / NCT07073833

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

NCT07073833

Phase 1 Recruiting 40 enrolled Imbioray (Hangzhou) Biomedicine Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-07-01
Primary completion
2027-07-30
Completion
2028-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject IBR900 Cell therapy
Subject Rituximab Monoclonal antibody