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Clinical Trial Summary

This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.


Clinical Trial Description

This study is a dose escalation study which adopts the 3+3 dose escalation design protocol. The dose is respectively 3.0×10^9 cells, 5.0×10^9 cells and 7.0×10^9 cells. The administration is performed on day 1 and day 8 of each cycle (21 days). 3-6 subjects will be enrolled at every dose level. The first and second subjects in the same group shall be enrolled at an interval of at least 7 days, for the purpose of ensuring their safety. Only when the dose-limiting toxicity (DLT) of all subjects in the previous dose group was observed can the enrollment of the next dose group get started. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06001684
Study type Interventional
Source Imbioray (Hangzhou) Biomedicine Co., Ltd.
Contact Ning Li, MD, PhD
Phone +86-010-87788787
Email cancergcp@163.com
Status Recruiting
Phase Phase 1
Start date September 1, 2023
Completion date December 30, 2024

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