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
A Phase I/IIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide to Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma
Cho Pharma Inc.
37 participants
Jan 15, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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).
Exclusion Criteria15
- 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).
Interventions
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).
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).
Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05950165