Phase
Condition
Marginal Zone Lymphoma
Lymphoma
Non-hodgkin's Lymphoma
Treatment
CHO-H01
CHO-H01 at RP2D
CHO-H01
Clinical Study ID
Ages > 18 All Genders
Study Summary
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:
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] 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:
At a daily dose higher than 15 mg prednisone or equivalent within 14 days priorto 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).
Study Design
Study Description
Connect with a study center
Taipei Medical University - Shuang Ho Hospital - Oncology
New Taipei City, Taipei Special Municipality 23561
TaiwanActive - Recruiting
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung, 833
TaiwanActive - Recruiting
China Medical University Hospital - Hematology/Oncology - Taichung
Taichung City, 404
TaiwanActive - Recruiting
National Cheng Kung University Hospital - Internal Medicine
Tainan, 70403
TaiwanActive - Recruiting
National Taiwan University Hospital - Hematology And Oncology
Taipei, 100
TaiwanActive - Recruiting
Tri-Service General Hospital - Neihu Branch - Hematology
Taipei, 11490
TaiwanActive - Recruiting
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
Taoyuan, 33305
TaiwanTerminated
Renovatio Clinical
The Woodlands, Texas 77389
United StatesSite Not Available
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