drugset / Trial / NCT05950165
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
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-01-15
- Primary completion
- 2026-12-23
- Completion
- 2026-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CHO-H01 | Monoclonal antibody | 0.5 mg/kg | Intravenous |
| Subject | CHO-H01 | Monoclonal antibody | 12 mg/kg | Intravenous |
| Background | Lenalidomide | Other / unclassified | 20 mg | Oral |