drugset / Trial / NCT03221348

A Phase I Study of Intravenous CHO-H01 in Patients With Refractory or Relapsed Follicular Lymphoma

NCT03221348

Phase 1 Unknown 24 enrolled Cho Pharma Inc.
SequentialOpen-labelTreatment

Summary

This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in subjects with follicular lymphoma. Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be evaluated to determine if it is appropriate to proceed with the additional 3 patients at that dose and schedule.

Timeline

Start
2018-03
Primary completion
2019-10
Completion
2019-11

Drugs

EvaluationDrugModalityDoseRoute
Subject CHO-H01 Monoclonal antibody 1 mg/kg Intravenous

Indications