Trial Title:
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
NCT ID:
NCT05950165
Condition:
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lenalidomide
Conditions: Keywords:
CHO-H01
Anti-CD20 Antibodies
Large B-cell lymphoma
Follicular lymphoma
Glyco-engineered anti-CD20 antibody
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
3+3 sequential cohort design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CHO-H01
Description:
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).
Arm group label:
CHO-H01
Intervention type:
Drug
Intervention name:
CHO-H01 at RP2D
Description:
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).
Arm group label:
CHO-H01+Lenalidomide
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day
cycle.
Arm group label:
CHO-H01+Lenalidomide
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.
Detailed description:
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 of CHO-H01 plus
lenalidomide in low-grade relapsed/refractory CD20 + non Hodgkin's lymphoma, including
follicular lymphoma (Grades 1-3a), marginal zone lymphoma, and small lymphocytic
lymphoma.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renovatio Clinical
Address:
City:
The Woodlands
Zip:
77389
Country:
United States
Status:
Withdrawn
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital - Oncology
Address:
City:
New Taipei City
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Address:
City:
Kaohsiung
Zip:
833
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital - Hematology/Oncology - Taichung
Address:
City:
Taichung City
Zip:
404
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital - Internal Medicine
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital - Hematology And Oncology
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Tri-Service General Hospital - Neihu Branch - Hematology
Address:
City:
Taipei
Zip:
11490
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
Address:
City:
Taoyuan
Zip:
33305
Country:
Taiwan
Status:
Terminated
Start date:
January 15, 2020
Completion date:
June 2026
Lead sponsor:
Agency:
Cho Pharma Inc.
Agency class:
Industry
Source:
Cho Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950165
