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

NCT05950165 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NHLHAT-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Non-Hodgkin Lymphoma

Keywords

CHO-H01; Anti-CD20 Antibodies; Large B-cell lymphoma; Follicular lymphoma; Glyco-engineered anti-CD20 antibody

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Serum concentration of CHO-HO1

  Through study completion, approximately 16 months

• Serum Antidrug antibody (ADA) concentration

  Through study completion, approximately 16 months

• Clinical benefit rate

  Through study completion, approximately 16 months

• Time to event endpoints of time to progression (TTP)

  Through study completion, approximately 16 months

• Duration of stable disease

  Through study completion, approximately 16 months

Study Arms (2)

CHO-H01

EXPERIMENTAL

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

CHO-H01+Lenalidomide

EXPERIMENTAL

Expansion phase with lenalidomide combination. Phase2a: Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.

Drug: CHO-H01 at RP2D; Drug: Lenalidomide

Interventions

CHO-H01 DRUG

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).

CHO-H01

CHO-H01 at RP2D DRUG

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).

CHO-H01+Lenalidomide

Lenalidomide DRUG

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

CHO-H01+Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;
• 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).

You may not qualify if:

• 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:
• At a daily dose higher than 15 mg prednisone or equivalent within 14 days prior to the first administration of CHO-H01;
• 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).

Sponsors & Collaborators

• Cho Pharma Inc.: lead

Study Sites (9)

Tri-Service General Hospital - Neihu Branch - Hematology

Taipei, Taipei, 11490, Taiwan

TERMINATED

Taipei Medical University - Shuang Ho Hospital - Oncology

New Taipei City, Taipei Special Municipality, 23561, Taiwan

RECRUITING

National Taiwan University Hospital Yunlin Branch

Huwei, Taiwan, 632, Taiwan

RECRUITING

Chi-Mei Medical Center

Tainan, Taiwan, 71004, Taiwan

RECRUITING

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

Taoyuan District, Taoyuan, 33305, Taiwan

TERMINATED

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

Kaohsiung City, 833, Taiwan

RECRUITING

China Medical University Hospital - Hematology/Oncology - Taichung

Taichung, 404, Taiwan

RECRUITING

National Cheng Kung University Hospital - Internal Medicine

Tainan, 70403, Taiwan

TERMINATED

National Taiwan University Hospital - Hematology And Oncology

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Tanny Tsao

CONTACT

886226558059; tanny.tsao@chopharma.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 sequential cohort design

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: January 15, 2020
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (9)