Non Hodgkin Lymphoma Clinical Trial
A Study to Assess Safety and Efficacy of CHO-H01 in 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 2 will assess the anticancer activity and safety of CHO-H01 in subjects with relapsed/refractory CD20+ non-Hodgkin's lymphoma.
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 in 2 cohorts of subjects with either aggressive B-cell lymphoma (DLBCL-NOS) or indolent (follicular) B-cell lymphoma, until intolerable toxicity or disease progression, withdrawal, or death occurs.
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, mantel 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,15 only:
Follicular lymphoma: Grades 1-3a;
DLBCL (NOS: to include germinal center B-cell-like [GCB] and activated B cell-like [ABC]).
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).
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 8 Locations for this study
The Woodlands Texas, 77389, United States
New Taipei City Taipei Special Municipality, 23561, Taiwan
Kaohsiung , 833, Taiwan
Taichung City , 404, Taiwan
Tainan , 70403, Taiwan
Taipei , 100, Taiwan
Taipei , 11490, Taiwan
Taoyuan , 33305, Taiwan
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.