NCT05411757

IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer

A Single-Arm, Open-Label Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Subjects With Advanced Primary Liver Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shandong Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, nonrandomized investigator-initiated clinical trial to evaluate the safety, tolerability, and efficacy of IBR900 cell injection in combination with Lenvatinib or bevacizumab in subjects with advanced primary liver cancer.

Detailed description

Two treatment groups are set up in this study. The first treatment group is IBR900 cell injection combined with Lenvatinib. The second treatment group is IBR900 cell injection combined with bevacizumab. Each cycle of the two treatment groups is 21 days. After 4 cycles of treatment, if the investigator judges that the subjects may benefit from continuing treatment, the subjects can continue to receive more cycles of treatment. 6 subjects are enrolled in each treatment group, and the group assignment of subjects is determined by the investigator. For subjects who have previously received Lenvatinib, they will not be able to continue to receive Lenvatinib after entering the study, but can be treated in combination with bevacizumab. For subjects who have previously received bevacizumab, they will not be able to continue to receive bevacizumab after entering the study, but can be treated in combination with Lenvatinib.

Conditions

• Advanced Primary Liver Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	IBR900 combined with Lenvatinib	IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Lenvatinib: body weight ≥ 60kg, 12mg/qd; body weight \< 60kg, 8mg/qd; administered continuously from D5 of the first cycle
COMBINATION_PRODUCT	IBR900 combined with Bevacizumab	IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Bevacizumab:15mg/kg, D1 of each cycle.

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2022-06-09
• Last updated: 2022-06-09