Actively Recruiting
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
Led by Cho Pharma Inc. · Updated on 2026-03-03
37
Participants Needed
9
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of more than 12 weeks
- Body mass index between 18 and 32 kg/m2
- ECOG performance status of 0 to 2
- Phase I: Histologically confirmed CD20-positive non-Hodgkin's lymphoma including low grade lymphoma (follicular lymphoma Grades 1-3a, marginal zone lymphoma, small lymphocytic lymphoma) and other lymphoma types (DLBCL, follicular lymphoma Grade 3b, mantle cell lymphoma, primary mediastinal large B-cell lymphoma)
- Phase IIa: Histologically confirmed low grade CD20-positive non-Hodgkin's lymphoma (follicular lymphoma Grades 1-3a, marginal zone lymphoma, small lymphocytic lymphoma)
- At least one measurable lesion at least 1.5 cm in size
- Off treatment for 30 days from last anti-CD20 infusion before starting CHO-H01
- Willing and able to provide a tumor biopsy if no original sample is available
- Adequate heart function without significant or uncontrolled heart disease
- Use of effective birth control methods as specified during and after the study
You will not qualify if you...
- History of egg allergy or allergic reactions to CHO-H01 components
- Known or current illnesses such as uncontrolled autoimmune diseases or infections that limit compliance or affect assessments
- Prior treatment with anti-PD-L1, PD-1, or CTLA-4 therapy
- Stem cell transplant within 100 days before CHO-H01 or allogeneic stem cell transplant
- Active hepatitis B or C infection with detectable viral load
- Known HIV infection
- Radiation therapy, major surgery, or live vaccinations within 28 days before CHO-H01
- History of severe allergic reactions to murine proteins or previous CD20 antibody infusions
- Use of systemic corticosteroids above specified doses within 14 days before CHO-H01
- Inadequate bone marrow, liver, or kidney function
- History of seizure disorder
- Pregnancy or breastfeeding
- Contraindications to lenalidomide (Phase IIa only)
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Tri-Service General Hospital - Neihu Branch - Hematology
Taipei, Taipei, Taiwan, 11490
Terminated
2
Taipei Medical University - Shuang Ho Hospital - Oncology
New Taipei City, Taipei Special Municipality, Taiwan, 23561
Actively Recruiting
3
National Taiwan University Hospital Yunlin Branch
Huwei, Taiwan, Taiwan, 632
Actively Recruiting
4
Chi-Mei Medical Center
Tainan, Taiwan, Taiwan, 71004
Actively Recruiting
5
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
Taoyuan, Taoyuan, Taiwan, 33305
Terminated
6
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City, Taiwan, 833
Actively Recruiting
7
China Medical University Hospital - Hematology/Oncology - Taichung
Taichung, Taiwan, 404
Actively Recruiting
8
National Cheng Kung University Hospital - Internal Medicine
Tainan, Taiwan, 70403
Terminated
9
National Taiwan University Hospital - Hematology And Oncology
Taipei, Taiwan, 100
Actively Recruiting
Research Team
T
Tanny Tsao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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