Assessing CHO-H01 for Non-Hodgkin's Lymphoma Treatment
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
This study is testing a new treatment called CHO-H01 for people with relapsed or hard-to-treat non-Hodgkin's lymphoma to see if it is safe and effective when combined with another medication.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cho Pharma Inc. Industry-sponsored |
| Drugs / interventions | radiation, prednisone |
| Locations | 9 sites (Taipei, Taipei and 8 other locations) |
| Trial ID | NCT05950165 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of CHO-H01, a glyco-engineered anti-CD20 antibody, in patients with relapsed or refractory CD20+ non-Hodgkin's lymphoma. The study is divided into two phases: Phase 1 focuses on determining the maximum tolerated dose and safety profile of CHO-H01, while Phase 2a assesses its anticancer activity when combined with lenalidomide. Participants will receive CHO-H01 via IV infusion, with treatment cycles lasting up to 19 weeks. The study aims to provide a new therapeutic option for patients with low-grade lymphoma.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed CD20+ non-Hodgkin's lymphoma who have a life expectancy of more than 12 weeks and meet specific health criteria.
Not a fit: Patients with non-CD20+ non-Hodgkin's lymphoma or those who are currently receiving other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with relapsed or refractory non-Hodgkin's lymphoma.
How similar studies have performed: Other studies involving anti-CD20 antibodies have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Taipei, Taipei and 8 other locations
- Tri-Service General Hospital - Neihu Branch - Hematology — Taipei, Taipei, Taiwan (Terminated)
- Taipei Medical University - Shuang Ho Hospital - Oncology — New Taipei City, Taipei Special Municipality, Taiwan (Recruiting)
- National Taiwan University Hospital Yunlin Branch — Huwei, Taiwan, Taiwan (Recruiting)
- Chi-Mei Medical Center — Tainan, Taiwan, Taiwan (Recruiting)
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology — Taoyuan, Taoyuan, Taiwan (Terminated)
- Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology — Kaohsiung City, Taiwan (Recruiting)
- China Medical University Hospital - Hematology/Oncology - Taichung — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital - Internal Medicine — Tainan, Taiwan (Terminated)
- National Taiwan University Hospital - Hematology And Oncology — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Tanny Tsao
- Email: tanny.tsao@chopharma.com.tw
- Phone: 886226558059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.