NCT07073833

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Imbioray (Hangzhou) Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	IBR900 cell injection	NK cells
DRUG	rituximab	CD20 antibody

Timeline

• Start date: 2025-07-20
• Primary completion: 2027-07-30
• Completion: 2028-07-30
• First posted: 2025-07-18
• Last updated: 2025-07-18

Locations

2 sites across 1 country: China