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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: CHO-H01; Drug: CHO-H01 at RP2D; Drug: Lenalidomide

Detailed Description

Phase I FIH study includes subjects with relapsed/refractory CD20 + non-Hodgkin's lymphoma, who may benefit from treatment with CHO-H01. In Phase I of the study, the first 2 cohorts will follow a 2-step modified accelerated titration dose escalation design and subsequent cohorts will follow a standard 3+3 dose escalation design.

The investigational medicinal product, CHO-H01, will be administered via IV infusion once weekly for 4 weeks in Cycle 1 and then once only (on Day 1) in each subsequent 21-day cycle until disease progression or for up to 6 cycles (19 weeks) of treatment.

Once the MTD/RP2D has been confirmed, Phase IIa of the study will be initiated. The purpose of Phase IIa is to assess anticancer activity and safety of CHO-H01 plus lenalidomide in low-grade relapsed/refractory CD20 + non Hodgkin's lymphoma, including follicular lymphoma (Grades 1-3a), marginal zone lymphoma, and small lymphocytic lymphoma.

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tanny Tsao; Phone Number: 886226558059; Email: tanny.tsao@chopharma.com.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospital - Hematology/Oncology - Taichung
  • Tainan, Taiwan, 70403
    • Terminated
    • National Cheng Kung University Hospital - Internal Medicine
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital - Hematology And Oncology
  • Taipei
    • Taipei, Taipei, Taiwan, 11490
      • Terminated
      • Tri-Service General Hospital - Neihu Branch - Hematology
  • Taipei Special Municipality
    • New Taipei City, Taipei Special Municipality, Taiwan, 23561
      • Recruiting
      • Taipei Medical University - Shuang Ho Hospital - Oncology
  • Taiwan
    • Huwei, Taiwan, Taiwan, 632
      • Recruiting
      • National Taiwan University Hospital Yunlin Branch
    • Tainan, Taiwan, Taiwan, 71004
      • Recruiting
      • Chi-Mei Medical Center
  • Taoyuan
    • Taoyuan District, Taoyuan, Taiwan, 33305
      • Terminated
      • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Life expectancy of >12 weeks.
• Body mass index of 18 to 32 kg/m2.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Phase I: Have histologically (laboratory test) confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification:

  1. Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;
  2. Other lymphoma: DLBCL (NOS: to include germinal center B-cell-like [GCB] and activated B-cell-like [ABC]), follicular lymphoma Grade 3b, mantle cell lymphoma; primary mediastinal large B-cell lymphoma.
• Phase IIa: Histologically confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification, only low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma.
• Have at least one measurable lesion that is at least 1.5 cm in its largest dimension.
• Off treatment for 30 days from last anti-CD20 infusion until planned administration of CHO-H01.
• If no original sample is available, is willing and able to provide an adequate tumor biopsy sample at Screening.
• Have adequate cardiac function: without clinically significant and/or uncontrolled heart disease.
• Must be sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or be committed to use an acceptable form of birth control for the duration of the study (male), and for the duration of the study and for 3 months following the last CHO-H01 administration (female).

Exclusion Criteria:

• Must not have a history of egg allergy or allergic reactions to any component of CHO-H01.
• Must not have any known or current illnesses (such as autoimmune disease, unless well controlled or resolved), infection, or other condition that could limit study compliance or interfere with assessments.
• Subjects who have received anti-programmed death-ligand 1 (PD-L1), programmed cell death 1 (PD-1), or cytotoxic T-lymphocyte associated protein 4 (CTLA-4) therapy.
• Subjects who have completed an autologous stem cell transplant within 100 days prior to CHO-H01 therapy or an allogeneic stem cell transplant.
• Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load.
• Subjects with known human immunodeficiency virus (HIV) infection
• Subjects who have had radiation therapy, major surgical procedure or live vaccinations within 28 days prior to CHO-H01 administration.
• Subjects with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies.

• Subjects who have received (or are receiving) systemic corticosteroids:

  1. At a daily dose higher than 15 mg prednisone or equivalent within 14 days prior to the first administration of CHO-H01;
  2. Topical, inhaled, nasal, and ophthalmic steroids are allowed.
• Inadequate bone marrow, hepatic or renal function.
• Subjects with a history of seizure disorder.
• Subjects who are pregnant or breast feeding.
• Subjects with any contraindications to lenalidomide (Only for phase IIa).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHO-H01; Dose escalation phase Phase 1: Five to six cohorts of escalating dose levels of CHO-H01 from 0.5mg/kg to 12 mg/kg.	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).
Experimental: CHO-H01+Lenalidomide; Expansion phase with lenalidomide combination. Phase2a: Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events (AE)	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.	Through study completion, approximately 16 months
Number of subjects with dose-limiting toxicities	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).	Through study completion, approximately 16 months
Objective Response Rate	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.	Through study completion, approximately 16 months
Best overall response	The best overall response (CR, PR, stable disease [SD], or progressive disease [PD]) is defined as the best response across all time points.	Through study completion, approximately 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of CHO-HO1	To characterize the PK of CHO-H01.	Through study completion, approximately 16 months
Serum Antidrug antibody (ADA) concentration	To investigate the immunogenicity of CHO-H01 alone and in combination with lenalidomide, using a validated bridging ADA assay.	Through study completion, approximately 16 months
Clinical benefit rate	The clinical benefit rate (CBR) is the proportion of subjects who achieve CR, PR, and durable SD (SD ≥12 weeks) based on the Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.	Through study completion, approximately 16 months
Time to event endpoints of time to progression (TTP)	Time to progression is the time from the date of first study dose to disease progression, evaluated using Modified (not using PET imaging)Lugano Revised Criteria for Response assessment.	Through study completion, approximately 16 months
Duration of stable disease	Duration of SD defined as the time interval, in the absence of either CR or PR, will be calculated between the date of the first CHO-H01 administration and the date of disease progression or death for any cause, whichever occurs earlier; based on the Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.	Through study completion, approximately 16 months
Progression-free survival	Progression-free survival (PFS) is the time from the date of first study dose to disease progression or death whichever occurs first in subjects, evaluated using Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.	Through study completion, approximately 16 months
Duration of response	Duration of response for responders (CR or PR) is the time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier; based on the Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.	Through study completion, approximately 16 months
Overall survival	The overall survival (OS) is the time from the date of the first study dose to the date of death (any cause), evaluated using Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.	Through study completion, approximately 16 months

Collaborators and Investigators

• Sponsor: Cho Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Follicular lymphoma; CHO-H01; Anti-CD20 Antibodies; Large B-cell lymphoma; Glyco-engineered anti-CD20 antibody
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide
• Other Study ID Numbers: NHLHAT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No