Actively Recruiting
A Phase IIIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 Alone or With Lenalidomide in Relapsed or Refractory Non-Hodgkins Lymphoma
Led by Cho Pharma Inc. · Updated on 2026-03-03
37
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and anticancer activity of CHO-H01 in adults with relapsed or refractory CD20-positive non-Hodgkins lymphoma. This study includes two parts Phase 1 focuses on finding the maximum tolerated and recommended doses of CHO-H01 alone, while Phase 2a assesses the combination of CHO-H01 with lenalidomide in patients with low-grade lymphoma types. The study aims to better understand treatment options for this condition, sponsored by Cho Pharma Inc. In Phase 1, participants receive intravenous infusions of CHO-H01 once weekly for 4 weeks during the first 28-day cycle, then once every 21-day cycle for up to 6 cycles or until disease progression. Dose levels range from 0.5 mgkg to 12 mgkg in escalating cohorts. After confirming the recommended dose, Phase 2a begins, where subjects receive the recommended dose of CHO-H01 combined with daily oral lenalidomide for 21 days in each 28-day cycle. Participants will undergo regular assessments including monitoring for adverse events, dose-limiting toxicities, and tumor response over approximately 16 months. Researchers will measure serum drug concentrations, immune responses, and clinical outcomes such as time to progression and survival. Safety and efficacy are closely followed through laboratory tests, imaging, and clinical evaluations during and after treatment to understand the benefits and risks of these therapies.
CONDITIONS
Brief 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...
- Age 18 years or older
- Life expectancy longer than 12 weeks
- Body mass index between 18 and 32 kg/m2
- ECOG performance status of 0 to 2
- Histologically confirmed CD20-positive non-Hodgkin's lymphoma per WHO 2016 classification
- For Phase I: Includes low grade lymphoma (follicular Grades 1-3a, marginal zone, small lymphocytic) and other lymphoma types including DLBCL, follicular Grade 3b, mantle cell, and primary mediastinal large B-cell lymphoma
- For Phase IIa: Only low-grade lymphoma types as above
- At least one measurable lesion 1.5 cm or larger
- Off treatment for 30 days from last anti-CD20 infusion before CHO-H01 administration
- Willing and able to provide tumor biopsy sample if no original sample available
- Adequate heart function without significant or uncontrolled heart disease
- Use of acceptable birth control methods during and after the study as specified
You will not qualify if you...
- History of egg allergy or allergic reactions to any component of CHO-H01
- Known or current illnesses such as uncontrolled autoimmune disease or infection that could limit study compliance
- Prior treatment with anti-PD-L1, PD-1, or CTLA-4 therapies
- Stem cell transplant within 100 days before CHO-H01 or any allogeneic transplant
- Active hepatitis B or hepatitis C infection with detectable viral load
- Known HIV infection
- Radiation therapy, major surgery, or live vaccinations within 28 days before CHO-H01
- History of type I hypersensitivity or anaphylaxis to murine proteins or CD20 monoclonal antibodies
- Systemic corticosteroids above 15 mg prednisone daily within 14 days before CHO-H01 (topical and inhaled steroids allowed)
- Inadequate bone marrow, liver, or kidney function
- History of seizure disorder
- Pregnant or breastfeeding
- Contraindications to lenalidomide (for Phase IIa)
Research Team
T
Tanny Tsao
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