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RECRUITING
NCT05950165
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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).

DRUG

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