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

Sponsor
Shandong Public Health Clinical Center
Study ID
NCT05411757
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Advanced Primary Liver Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBR900 combined with Lenvatinib — COMBINATION_PRODUCT
    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
  • IBR900 combined with Bevacizumab — COMBINATION_PRODUCT
    IBR900 cell injection: 4.0×10\^9 cells, D1,D3 of each cycle. Bevacizumab:15mg/kg, D1 of each cycle.

Study Details

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.

Key Dates

First listed
Jun 9, 2022
Start date
Jun 30, 2022
Status verified
Jun 2022
Primary completion
Jun 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IBR900 cell injection
    IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: From day 1 to day 90 after the last infusion ]

Central Contacts