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
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).
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).
Lenalidomide: Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Number of subjects with adverse events (AE) — Through study completion, approximately 16 months 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.
Number of subjects with dose-limiting toxicities — Through study completion, approximately 16 months 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).
Objective Response Rate — Through study completion, approximately 16 months 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.
Best overall response — Through study completion, approximately 16 months The best overall response (CR, PR, stable disease \[SD\], or progressive disease \[PD\]) is defined as the best response across all time points.
Trial sites (9)
Facility
City
Region
Status
Tri-Service General Hospital - Neihu Branch - Hematology
Taipei
Taipei
Taipei Medical University - Shuang Ho Hospital - Oncology
New Taipei City
Taipei Special Municipality
National Taiwan University Hospital Yunlin Branch
Huwei
Taiwan
Chi-Mei Medical Center
Tainan
Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
Taoyuan
Taoyuan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City
Taiwan
China Medical University Hospital - Hematology/Oncology - Taichung
Taichung
Taiwan
National Cheng Kung University Hospital - Internal Medicine
Tainan
Taiwan
National Taiwan University Hospital - Hematology And Oncology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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