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
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of subjects with adverse events (AE) — Through study completion, approximately 16 months
To assess the safety and tolerability of CHO-H01 as a single agent in subjects with relapsed/refractory CD20 + non-Hodgkin's lymphoma and CHO-H01 plus lenalidomide in subjects with low-grade relapsed/refractory CD20 + non-Hodgkin's lymphoma. - Number of subjects with dose-limiting toxicities — Through study completion, approximately 16 months
All AEs and toxicities are evaluated based on the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0. The 5 general grades are Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death (outcome of AE). - Objective Response Rate — Through study completion, approximately 16 months
Objective response rate (ORR) is the proportion of subjects with a best overall response of complete response (CR) or partial response (PR). ORR will be measured based on Modified (not using PET imaging) Lugano Revised Criteria for Response assessment. - Best overall response — Through study completion, approximately 16 months
The best overall response (CR, PR, stable disease \[SD\], or progressive disease \[PD\]) is defined as the best response across all time points.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Tri-Service General Hospital - Neihu Branch - Hematology | Taipei | Taipei | |
| Taipei Medical University - Shuang Ho Hospital - Oncology | New Taipei City | Taipei Special Municipality | |
| National Taiwan University Hospital Yunlin Branch | Huwei | Taiwan | |
| Chi-Mei Medical Center | Tainan | Taiwan | |
| Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology | Taoyuan | Taoyuan | |
| 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 |
On this site
📄 Revlimid (lenalidomide) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05950165 on ClinicalTrials.gov ↗ ← All trials in China