Clinical Trials List
Protocol NumberNHLHAT-001
NCT Number(ClinicalTrials.gov Identfier)NCT
2019-09-15 - 2027-05-31
Phase I/II
Not yet recruiting1
Recruiting6
ICD-10C85.98
Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites
A Phase I/IIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 as a Single Agent to Subjects with Refractory or Relapsed Non-Hodgkin's Lymphoma
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
CHO Pharma Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Po-Nan Wang Division of Hematology & Oncology
- HSUAN JEN SHIH Division of Hematology & Oncology
- 高小雯 Division of Hematology & Oncology
- Tung-Liang Lin Division of Hematology & Oncology
- 王博 Division of Hematology & Oncology
- 蘇羿囷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chieh-Lung Cheng Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- 劉家豪 Division of Hematology & Oncology
- Tai-Chung Huang Division of Hematology & Oncology
- - - Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Refractory or Relapsed Non-Hodgkin's Lymphoma
Objectives
Phase I
Primary Objectives
•To assess the safety and tolerability of CHO-H01 in subjects with relapsed/refractory CD20 + non-Hodgkin’s lymphoma;
•To assess dose-limiting toxicity (DLT) and to determine the MTD and the RP2D for CHO-H01 when administered IV on a weekly schedule for 4 weeks and then once per 28-day cycle on Day 1 of subsequent cycles for a total of 9 months or until disease progression.
Phase IIa (At the Recommended Phase II Dose)
Primary Objectives
•To assess the safety and tolerability of CHO-H01 in subjects with relapsed/refractory CD20 + non-Hodgkin’s lymphoma of the DLBCL and follicular subtypes;
•To assess clinical activity of CHO-H01 when administered IV on a weekly schedule for 4 weeks and then once per 28-day cycle on Day 1 of subsequent cycles for a total of 9 months or until disease progression.
Test Drug
CHO-H01
Active Ingredient
CHO-H01
Dosage Form
IVT
Dosage
10mL/Vial
Endpoints
Primary Endpoints:
Phase I:
•Safety and tolerability: Assessed by AEs, vital signs, ECG, clinical laboratory tests, physical examination, ECOG performance status, and baseline medical conditions;
•Dose escalation and determination of the MTD and RP2D based on DLTs during Cycle 1 (ie, 28-day cycle). The RP2D will be determined using Cycle 1 information as well as available subsequent CHO-H01 treatment information.
Phase IIa:
•Safety and tolerability at the RP2D: Assessed by AEs, vital signs, ECG, clinical laboratory tests, physical examination, ECOG performance status, and baseline medical conditions;
•Clinical response: Evidence of antitumor activity (detailed under Anticancer Activity Parameters below) based on the Lugano Revised Criteria for Response assessment and ECOG performance status for symptomatic improvement.
Secondary Endpoints:
Phase I:
•Pharmacokinetics: CHO-H01 serum concentration-time profiles and derived PK parameters as defined below under Pharmacokinetics;
•Immunogenicity: Frequency of ADAs, neutralizing antibodies, titers, and time to antibody formation, as appropriate;
•Clinical response: Evaluation of antitumor activity (detailed under Anticancer Activity Parameters below) based on the Lugano Revised Criteria for Response assessment and ECOG performance status for symptomatic improvement.
Phase IIa:
•Pharmacokinetics: CHO-H01 serum concentration-time profiles and derived PK parameters as defined below under Pharmacokinetics;
•Immunogenicity: Frequency of ADAs, neutralizing antibodies, titers, and time to antibody formation, as appropriate.
Exploratory Endpoint:
Phase I:
•Pharmacodynamic: CD19+ B-cell counts and measures of B-cell depletion, as well as the presence and subtype of immune cells and their biomarkers.
Phase IIa:
•Glycan concentrations in serum;
•Pharmacodynamic: CD19+ B-cell counts and measures of B-cell depletion, as well as the presence and subtype of immune cells and their biomarkers.
Phase I:
•Safety and tolerability: Assessed by AEs, vital signs, ECG, clinical laboratory tests, physical examination, ECOG performance status, and baseline medical conditions;
•Dose escalation and determination of the MTD and RP2D based on DLTs during Cycle 1 (ie, 28-day cycle). The RP2D will be determined using Cycle 1 information as well as available subsequent CHO-H01 treatment information.
Phase IIa:
•Safety and tolerability at the RP2D: Assessed by AEs, vital signs, ECG, clinical laboratory tests, physical examination, ECOG performance status, and baseline medical conditions;
•Clinical response: Evidence of antitumor activity (detailed under Anticancer Activity Parameters below) based on the Lugano Revised Criteria for Response assessment and ECOG performance status for symptomatic improvement.
Secondary Endpoints:
Phase I:
•Pharmacokinetics: CHO-H01 serum concentration-time profiles and derived PK parameters as defined below under Pharmacokinetics;
•Immunogenicity: Frequency of ADAs, neutralizing antibodies, titers, and time to antibody formation, as appropriate;
•Clinical response: Evaluation of antitumor activity (detailed under Anticancer Activity Parameters below) based on the Lugano Revised Criteria for Response assessment and ECOG performance status for symptomatic improvement.
Phase IIa:
•Pharmacokinetics: CHO-H01 serum concentration-time profiles and derived PK parameters as defined below under Pharmacokinetics;
•Immunogenicity: Frequency of ADAs, neutralizing antibodies, titers, and time to antibody formation, as appropriate.
Exploratory Endpoint:
Phase I:
•Pharmacodynamic: CD19+ B-cell counts and measures of B-cell depletion, as well as the presence and subtype of immune cells and their biomarkers.
Phase IIa:
•Glycan concentrations in serum;
•Pharmacodynamic: CD19+ B-cell counts and measures of B-cell depletion, as well as the presence and subtype of immune cells and their biomarkers.
Inclution Criteria
Inclusion Criteria (all must be met to qualify for enrollment):
•Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol;
•Female or male subjects aged ≥18 years; •Life expectancy of >12 weeks;
•Histologically confirmed CD20 + non-Hodgkin’s lymphoma;
•Subjects must have relapsed/refractory CD20 + non-Hodgkin’slymphomas that has failed treatment or whose cancer has progressed following available standard therapy or for whom such therapy was not acceptable;
•Disease measurability: At least one bi-dimensionally measurable lesion that is at least 1.5 cm in its largest dimension.
•ECOG performance status of 0 to 2;
•Off treatment for 30 days from last anti-CD20 infusion until planned administration of CHO-H01 according to this protocol;
•Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE; Version 5.0) Grade 0 or 1;
•Subject must be willing and able to provide an adequate archival sample at Screening. An archival tumor biopsy (ie, tissue block or series of approximately 10 slides) is required, and should be provided during the Screening period. A fresh tumor biopsy must be performed if no original sample is available;
•Adequate cardiac function as assessed by the investigator based on electrocardiogram (ECG) and cardiac ultrasound findings;
•Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or be at least 2 years postmenopausal, or commit to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 3 months following the last CHO-H01 administration;•Body mass index of 18 to 32 kg/m2;
•Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study;
•Availability to attend visits according to the protocol
•Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol;
•Female or male subjects aged ≥18 years; •Life expectancy of >12 weeks;
•Histologically confirmed CD20 + non-Hodgkin’s lymphoma;
•Subjects must have relapsed/refractory CD20 + non-Hodgkin’slymphomas that has failed treatment or whose cancer has progressed following available standard therapy or for whom such therapy was not acceptable;
•Disease measurability: At least one bi-dimensionally measurable lesion that is at least 1.5 cm in its largest dimension.
•ECOG performance status of 0 to 2;
•Off treatment for 30 days from last anti-CD20 infusion until planned administration of CHO-H01 according to this protocol;
•Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE; Version 5.0) Grade 0 or 1;
•Subject must be willing and able to provide an adequate archival sample at Screening. An archival tumor biopsy (ie, tissue block or series of approximately 10 slides) is required, and should be provided during the Screening period. A fresh tumor biopsy must be performed if no original sample is available;
•Adequate cardiac function as assessed by the investigator based on electrocardiogram (ECG) and cardiac ultrasound findings;
•Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or be at least 2 years postmenopausal, or commit to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 3 months following the last CHO-H01 administration;•Body mass index of 18 to 32 kg/m2;
•Male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study;
•Availability to attend visits according to the protocol
Exclusion Criteria
Exclusion Criteria (any subject who meets any of these criteria should be excluded from the study):
•Subjects with a history of egg allergy or allergic reactions to any component of CHO-H01;
•Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 30 days (or 2 half-lives for proteins) whichever is longer, prior to the first administration of CHO-H01 (to satisfy the recognized requirement of at least 5 times the terminal half-life period for most drugs currently used, including most receptor tyrosine kinase inhibitors);
•Subjects who have received systemic corticosteroids at a daily dose higher than 15 mg prednisone or equivalent within 7 days prior to the first administration of CHO-H01, excluding prednisolone or equivalent ≤10 mg/day;
•Subjects with a history of seizure disorder;
•Subjects with a known history of central nervous system metastases or seizure disorder related to the malignancy; however, those subjects who were treated for prior central nervous system metastases and who are asymptomatic may participate in the study as long as they are not receiving treatment with non-normal physiologic doses of steroids;
•Subjects with a history of symptomatic congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia requiring therapy;•Inadequate bone marrow function defined by: absolute neutrophil count of <1.5 × 109/L, platelet count of <75 × 109/L, and hemoglobin < 9.0 g/dL;
•Inadequate hepatic function defined by: serum total bilirubin ≥1.5 the ULN, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × the upper limit of normal (ULN) (or >5 × ULN in subjects with liver metastases);
•Inadequate renal function defined by: serum creatinine > 1.5 times the upper limit of normal (ULN)(unless normal creatinine clearance), or calculated creatinine clearance (by Cockcroft-Gault formula) < 40 mL/min;
•Subjects with any uncontrolled intercurrent illness, infection, or other condition that could limit study compliance or interfere with assessments;
•Subjects who are pregnant or breast feeding;•Refusal to use effective methods of contraception (see inclusion criteria for details);
•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 within 6 months;
•Subjects who have completed an autologous stem cell transplant within 100 days prior to the first administration of CHO-H01;
•Subjects who have completed an allogenic stem cell transplant;
•Subjects with a history of progressive multi-focal leukoencephalopathy;
•Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection. Note: patients who have isolated positive hepatitis B core antibody and /or positive hepatitis B surface antibody (ie, in the setting of negative HBsAg) may be included if they have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load;
•Subjects with known human immunodeficiency virus (HIV) infection;
•Subjects who have had radiation therapy within 28 days prior to the first administration of CHO-H01;
•Subjects with a major surgical procedure within 28 days the first administration of CHO-H01 or with ongoing postoperative complications if more than 21 days;
•Subjects who have had live vaccinations within 28 days the first administration of CHO-H01;
•Subjects with elevated lymphocyte counts of >25 × 109/L;
•Subjects with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies;
•Legal incapacity/limited legal capacity for provision of informed consent
•Subjects with a history of egg allergy or allergic reactions to any component of CHO-H01;
•Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 30 days (or 2 half-lives for proteins) whichever is longer, prior to the first administration of CHO-H01 (to satisfy the recognized requirement of at least 5 times the terminal half-life period for most drugs currently used, including most receptor tyrosine kinase inhibitors);
•Subjects who have received systemic corticosteroids at a daily dose higher than 15 mg prednisone or equivalent within 7 days prior to the first administration of CHO-H01, excluding prednisolone or equivalent ≤10 mg/day;
•Subjects with a history of seizure disorder;
•Subjects with a known history of central nervous system metastases or seizure disorder related to the malignancy; however, those subjects who were treated for prior central nervous system metastases and who are asymptomatic may participate in the study as long as they are not receiving treatment with non-normal physiologic doses of steroids;
•Subjects with a history of symptomatic congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia requiring therapy;•Inadequate bone marrow function defined by: absolute neutrophil count of <1.5 × 109/L, platelet count of <75 × 109/L, and hemoglobin < 9.0 g/dL;
•Inadequate hepatic function defined by: serum total bilirubin ≥1.5 the ULN, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × the upper limit of normal (ULN) (or >5 × ULN in subjects with liver metastases);
•Inadequate renal function defined by: serum creatinine > 1.5 times the upper limit of normal (ULN)(unless normal creatinine clearance), or calculated creatinine clearance (by Cockcroft-Gault formula) < 40 mL/min;
•Subjects with any uncontrolled intercurrent illness, infection, or other condition that could limit study compliance or interfere with assessments;
•Subjects who are pregnant or breast feeding;•Refusal to use effective methods of contraception (see inclusion criteria for details);
•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 within 6 months;
•Subjects who have completed an autologous stem cell transplant within 100 days prior to the first administration of CHO-H01;
•Subjects who have completed an allogenic stem cell transplant;
•Subjects with a history of progressive multi-focal leukoencephalopathy;
•Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection. Note: patients who have isolated positive hepatitis B core antibody and /or positive hepatitis B surface antibody (ie, in the setting of negative HBsAg) may be included if they have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load;
•Subjects with known human immunodeficiency virus (HIV) infection;
•Subjects who have had radiation therapy within 28 days prior to the first administration of CHO-H01;
•Subjects with a major surgical procedure within 28 days the first administration of CHO-H01 or with ongoing postoperative complications if more than 21 days;
•Subjects who have had live vaccinations within 28 days the first administration of CHO-H01;
•Subjects with elevated lymphocyte counts of >25 × 109/L;
•Subjects with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies;
•Legal incapacity/limited legal capacity for provision of informed consent
The Estimated Number of Participants
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Taiwan
50 participants
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Global
60 participants
