RecruitingPhase 1Phase 2NCT05950165

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

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

Sponsor

Cho Pharma Inc.

Enrollment

37 participants

Start Date

Jan 15, 2020

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called CHO-H01, alone or combined with lenalidomide, in people with non-Hodgkin's lymphoma (NHL) that has come back or stopped responding to previous treatments. CHO-H01 targets a protein called CD20 found on lymphoma cells. **You may be eligible if...** - You are 18 or older with confirmed CD20-positive non-Hodgkin's lymphoma (types include follicular lymphoma, marginal zone lymphoma, DLBCL, mantle cell lymphoma, and others) - Your cancer has returned or not responded to prior treatment - You have at least one measurable tumor (at least 1.5 cm) - Your heart, liver, kidneys, and bone marrow are functioning adequately - You have not had an anti-CD20 infusion (like rituximab) in the past 30 days **You may NOT be eligible if...** - You are allergic to eggs or to components of CHO-H01 - You are HIV positive or have active hepatitis B or C - You have had an autologous (self) stem cell transplant in the last 100 days - You have had an allogeneic (donor) stem cell transplant - You have a history of seizures - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCHO-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).

DRUGCHO-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).

DRUGLenalidomide

Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.