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A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma
Sponsor: Cho Pharma Inc.
Summary
This is a 2-part study. Part 1/Phase 1 of the study will be conducted to determine the safety and tolerability of CHO-H01 in subjects with relapsed/refractory CD20+ non-Hodgkin's lymphoma. It will also determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Part 2/Phase 2a will assess the anticancer activity and safety of CHO-H01 plus lenalidomide in subjects with low-grade relapsed/refractory CD20+ non-Hodgkin's lymphoma.
Official title: A Phase I/IIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide to Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2020-01-15
Completion Date
2026-12-23
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
CHO-H01
Phase 1: Subjects will be administered intravenous (IV) infusion of assigned dose level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle). From Cycle 2 onwards, on Day 1 of each subsequent 21-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).
CHO-H01 at RP2D
Subjects will be administered intravenous (IV) infusion of RP2D level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle). From Cycle 2 onwards, on Day 1 of each subsequent 28-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).
Lenalidomide
Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.
Locations (9)
Tri-Service General Hospital - Neihu Branch - Hematology
Taipei, Taipei, Taiwan
Taipei Medical University - Shuang Ho Hospital - Oncology
New Taipei City, Taipei Special Municipality, Taiwan
National Taiwan University Hospital Yunlin Branch
Huwei, Taiwan, Taiwan
Chi-Mei Medical Center
Tainan, Taiwan, Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
Taoyuan District, Taoyuan, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City, Taiwan
China Medical University Hospital - Hematology/Oncology - Taichung
Taichung, Taiwan
National Cheng Kung University Hospital - Internal Medicine
Tainan, Taiwan
National Taiwan University Hospital - Hematology And Oncology
Taipei, Taiwan