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

Last updated: March 13, 2025
Sponsor: Cho Pharma Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Marginal Zone Lymphoma

Lymphoma

Non-hodgkin's Lymphoma

Treatment

CHO-H01

CHO-H01 at RP2D

CHO-H01

Clinical Study ID

NCT05950165
NHLHAT-001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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'slymphoma 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] andactivated B-cell-like [ABC]), follicular lymphoma Grade 3b, mantle celllymphoma; primary mediastinal large B-cell lymphoma.

  • Phase IIa: Histologically confirmed CD20 + non-Hodgkin's lymphoma according to theWorld Health Organization's 2016 classification, only low grade lymphoma: follicularlymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma.

  • Have at least one measurable lesion that is at least 1.5 cm in its largestdimension.

  • Off treatment for 30 days from last anti-CD20 infusion until planned administrationof CHO-H01.

  • If no original sample is available, is willing and able to provide an adequate tumorbiopsy sample at Screening.

  • Have adequate cardiac function: without clinically significant and/or uncontrolledheart 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 controlfor the duration of the study (male), and for the duration of the study and for 3months following the last CHO-H01 administration (female).

Exclusion

Exclusion Criteria:

  • Must not have a history of egg allergy or allergic reactions to any component ofCHO-H01.

  • Must not have any known or current illnesses (such as autoimmune disease, unlesswell controlled or resolved), infection, or other condition that could limit studycompliance or interfere with assessments.

  • Subjects who have received anti-programmed death-ligand 1 (PD-L1), programmed celldeath 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 priorto CHO-H01 therapy or an allogeneic stem cell transplant.

  • Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known orsuspected 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 livevaccinations within 28 days prior to CHO-H01 administration.

  • Subjects with a history of type I hypersensitivity or anaphylactic reactions tomurine 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 priorto 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 Design

Total Participants: 37
Treatment Group(s): 4
Primary Treatment: CHO-H01
Phase: 1/2
Study Start date:
January 15, 2020
Estimated Completion Date:
December 23, 2026

Study 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.

Connect with a study center

  • Taipei Medical University - Shuang Ho Hospital - Oncology

    New Taipei City, Taipei Special Municipality 23561
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

    Kaohsiung, 833
    Taiwan

    Active - Recruiting

  • China Medical University Hospital - Hematology/Oncology - Taichung

    Taichung City, 404
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital - Internal Medicine

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital - Hematology And Oncology

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital - Neihu Branch - Hematology

    Taipei, 11490
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology

    Taoyuan, 33305
    Taiwan

    Terminated

  • Renovatio Clinical

    The Woodlands, Texas 77389
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.