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Non-Hodgkin LymphomaPhase 1/2NCT05950165

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

A Phase 1/2 study testing CHO-H01, CHO-H01 at RP2D and Lenalidomide in people with Non-Hodgkin Lymphoma, run by Cho Pharma Inc. at 9 sites in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
CHO-H01, CHO-H01 at RP2D and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
9 sitesTaiwan
Study dates
15 Jan 2020to 23 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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:
  • 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.
  • Subjects with a history of seizure disorder.
  • Subjects who are pregnant or breast feeding.
  • Subjects with any contraindications to lenalidomide (Only for phase IIa).

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Taiwan9 sites

  • National Taiwan University Hospital Yunlin Branch

    Huwei, Taiwan, 632

  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

    Kaohsiung City, 833

  • Taipei Medical University - Shuang Ho Hospital - Oncology

    New Taipei City, Taipei Special Municipality, 23561

  • China Medical University Hospital - Hematology/Oncology - Taichung

    Taichung, 404

  • Chi-Mei Medical Center

    Tainan, Taiwan, 71004

  • National Cheng Kung University Hospital - Internal Medicine

    Tainan, 70403

  • Tri-Service General Hospital - Neihu Branch - Hematology

    Taipei, Taipei, 11490

  • National Taiwan University Hospital - Hematology And Oncology

    Taipei, 100

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology

    Taoyuan, Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: 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 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.

Read the 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.

Being tested
CHO-H01, CHO-H01 at RP2D, Lenalidomide
Keywords
CHO-H01, Anti-CD20 Antibodies, Large B-cell lymphoma, Follicular lymphoma, Glyco-engineered anti-CD20 antibody
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHO-H01Drug

    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).

  • CHO-H01 at RP2DDrug

    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).

  • LenalidomideDrug

    Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.

Study groups in NCT05950165
Study groupRoleWhat they receive
CHO-H01ExperimentalDose escalation phase Phase 1: Five to six cohorts of escalating dose levels of CHO-H01 from 0.5mg/kg to 12 mg/kg.
Receives: Drug: CHO-H01
CHO-H01+LenalidomideExperimentalExpansion phase with lenalidomide combination. Phase2a: Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.
Receives: Drug: CHO-H01 at RP2D; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events (AE)

    To assess the safety and tolerability of CHO-H01 as a single agent in subjects with relapsed/refractory CD20 + non-Hodgkin's lymphoma and CHO-H01 plus lenalidomide in subjects with low-grade relapsed/refractory CD20 + non-Hodgkin's lymphoma.

    Measured: Through study completion, approximately 16 months

  2. Number of subjects with dose-limiting toxicities

    All AEs and toxicities are evaluated based on the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0. The 5 general grades are Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death (outcome of AE).

    Measured: Through study completion, approximately 16 months

  3. Objective Response Rate

    Objective response rate (ORR) is the proportion of subjects with a best overall response of complete response (CR) or partial response (PR). ORR will be measured based on Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

  4. Best overall response

    The best overall response (CR, PR, stable disease [SD], or progressive disease [PD]) is defined as the best response across all time points.

    Measured: Through study completion, approximately 16 months

Secondary outcomes (8)

  1. Serum concentration of CHO-HO1

    To characterize the PK of CHO-H01.

    Measured: Through study completion, approximately 16 months

  2. Serum Antidrug antibody (ADA) concentration

    To investigate the immunogenicity of CHO-H01 alone and in combination with lenalidomide, using a validated bridging ADA assay.

    Measured: Through study completion, approximately 16 months

  3. Clinical benefit rate

    The clinical benefit rate (CBR) is the proportion of subjects who achieve CR, PR, and durable SD (SD ≥12 weeks) based on the Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

  4. Time to event endpoints of time to progression (TTP)

    Time to progression is the time from the date of first study dose to disease progression, evaluated using Modified (not using PET imaging)Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

  5. Duration of stable disease

    Duration of SD defined as the time interval, in the absence of either CR or PR, will be calculated between the date of the first CHO-H01 administration and the date of disease progression or death for any cause, whichever occurs earlier; based on the Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

  6. Progression-free survival

    Progression-free survival (PFS) is the time from the date of first study dose to disease progression or death whichever occurs first in subjects, evaluated using Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

  7. Duration of response

    Duration of response for responders (CR or PR) is the time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier; based on the Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

  8. Overall survival

    The overall survival (OS) is the time from the date of the first study dose to the date of death (any cause), evaluated using Modified (not using PET imaging) Lugano Revised Criteria for Response assessment.

    Measured: Through study completion, approximately 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start15 Jan 2020
  3. Primary completion23 Dec 2026 (estimated)
  4. Study completion23 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
3+3 sequential cohort design
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05950165
Sponsor's protocol ID
NHLHAT-001
Status last verified
Aug 2026
First submitted
10 Jul 2023
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHO-H01, CHO-H01 at RP2D and Lenalidomide in people with Non-Hodgkin Lymphoma, run by Cho Pharma Inc. at 9 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events (AE) (time frame: Through study completion, approximately 16 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05950165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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