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Tests treatment safety and results for Non-Hodgkin Lymphoma
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
ClinicalTrials.gov ID: NCT05950165
What this study is testing
What is CHO-H01?
CHO-H01 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;
You likely can't join if
- 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...
- people who have received anti-programmed death-ligand 1 (PD-L1), programmed cell death 1 (PD-1), or cytotoxic T-lymphocyte associated protein 4...
- people who have completed an autologous stem cell transplant within 100 days prior to CHO-H01 therapy or an allogeneic stem cell transplant.
- people with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load.
- people with known human immunodeficiency virus (HIV) infection
See the full eligibility 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:
- 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...
- 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...
- 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.
- people 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.
- people who have completed an autologous stem cell transplant within 100 days prior to CHO-H01 therapy or an allogeneic stem cell transplant.
- people with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load.
- people with known human immunodeficiency virus (HIV) infection
- people who have had radiation therapy, major surgical procedure or live vaccinations within 28 days prior to CHO-H01 administration.
- people with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies.
- people 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.
- people with a history of seizure disorder.
- people who are pregnant or breast feeding.
- people with any contraindications to lenalidomide (Only for phase IIa).
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taipei, Taiwan
- New Taipei City, Taipei Special Municipality, Taiwan
- Huwei, Taiwan, Taiwan
- Tainan, Taiwan, Taiwan
- Taoyuan, Taoyuan, Taiwan
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taipei, Taiwan; New Taipei City, Taipei Special Municipality, Taiwan; Huwei, Taiwan, Taiwan; Tainan, Taiwan, Taiwan; Taoyuan, Taoyuan, Taiwan; Kaohsiung City, Taiwan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.