Back to resultsA Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas
Primary Purpose
B-cell Lymphomas
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HLX01
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Lymphomas
Eligibility Criteria
Inclusion Criteria:
- 18 years ≤ aged ≤ 65 years, male or female;
- having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
- providing signed and dated informed consents.
Exclusion Criteria:
- Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
- usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
- recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
- peripheral nervous system diseases or central nervous system diseases;
- inadequate hematologic function met any of the following at screening: white blood cell count <3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) <1.0×109/L, platelet count <75×109/L, hemoglobin <80 g/L;
- inadequate liver function met any of the following at screening: total bilirubin>1.5×the upper limit of normal range (ULN), ALT or AST>2.0×ULN, alkaline phosphatase (ALP)>3.0×ULN;
- abnormal renal function (serum creatinine>1.5×ULN);
- abnormal thyroid function (TSH< lower limit of normal or > upper limit of normal with clinical significance judged by investigators);
- positive test result(s) for serum HIV antigen or antibody;
- seropositivity of HBsAg, or seropositivity of HBcAb and HBV DNA>ULN; seropositivity of Anti HCV antibody;
- history of herpes zoster and left with sequelae or latent infection;
- other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.);
- pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study;
- allergic constitution, or known allergic to components of rituximab or other anti-CD20 monoclonal antibody;
- history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment;
- not suitable for enrollment at investigator's discretion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
HLX01 250 mg/m2
HLX01 375 mg/m2
HLX01 500 mg/m2
Arm Description
HLX01 250 mg/m2 administrated intravenously
HLX01 375 mg/m2 administrated intravenously
HLX01 500 mg/m2 administrated intravenously
Outcomes
Primary Outcome Measures
AEs
The type, severity and incidence of adverse events
SAEs
Thetype, severity and incidence of SAEs
Secondary Outcome Measures
AUC0-inf
Area under the serum concentration-time curve from time 0 extrapolated to infinity
Cmax
Maximum serum concentration
t1/2
terminal half-life
CD19 positive B cells
The count of CD19 positive in peripheral blood
CD20 positive B cells
The count of CD20 positive in peripheral blood
Antidrug antibodies of HLX01
The concentration of anti-HLX01 in serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03218072
Brief Title
A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas
Official Title
A Phase Ia, Multi-centers, Open-label, Dose-escalation Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HLX01 (a Potential Rituximab Biosimilar) in Patients With CD20-positive B-cell Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2014 (Actual)
Primary Completion Date
January 31, 2015 (Actual)
Study Completion Date
January 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
5. Study Description
Brief Summary
To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
Detailed Description
This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HLX01 250 mg/m2
Arm Type
Experimental
Arm Description
HLX01 250 mg/m2 administrated intravenously
Arm Title
HLX01 375 mg/m2
Arm Type
Experimental
Arm Description
HLX01 375 mg/m2 administrated intravenously
Arm Title
HLX01 500 mg/m2
Arm Type
Experimental
Arm Description
HLX01 500 mg/m2 administrated intravenously
Intervention Type
Drug
Intervention Name(s)
HLX01
Intervention Description
a potential rituximab biosimilar
Primary Outcome Measure Information:
Title
AEs
Description
The type, severity and incidence of adverse events
Time Frame
From First infusion to Day 90
Title
SAEs
Description
Thetype, severity and incidence of SAEs
Time Frame
From First infusion to Day 90
Secondary Outcome Measure Information:
Title
AUC0-inf
Description
Area under the serum concentration-time curve from time 0 extrapolated to infinity
Time Frame
From First administration to Day 90
Title
Cmax
Description
Maximum serum concentration
Time Frame
From First administration to Day 90
Title
t1/2
Description
terminal half-life
Time Frame
From First administration to Day 90
Title
CD19 positive B cells
Description
The count of CD19 positive in peripheral blood
Time Frame
From First administration to Day 90
Title
CD20 positive B cells
Description
The count of CD20 positive in peripheral blood
Time Frame
From First administration to Day 90
Title
Antidrug antibodies of HLX01
Description
The concentration of anti-HLX01 in serum
Time Frame
From First administration to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years ≤ aged ≤ 65 years, male or female;
having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
providing signed and dated informed consents.
Exclusion Criteria:
Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
peripheral nervous system diseases or central nervous system diseases;
inadequate hematologic function met any of the following at screening: white blood cell count <3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) <1.0×109/L, platelet count <75×109/L, hemoglobin <80 g/L;
inadequate liver function met any of the following at screening: total bilirubin>1.5×the upper limit of normal range (ULN), ALT or AST>2.0×ULN, alkaline phosphatase (ALP)>3.0×ULN;
abnormal renal function (serum creatinine>1.5×ULN);
abnormal thyroid function (TSH< lower limit of normal or > upper limit of normal with clinical significance judged by investigators);
positive test result(s) for serum HIV antigen or antibody;
seropositivity of HBsAg, or seropositivity of HBcAb and HBV DNA>ULN; seropositivity of Anti HCV antibody;
history of herpes zoster and left with sequelae or latent infection;
other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.);
pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study;
allergic constitution, or known allergic to components of rituximab or other anti-CD20 monoclonal antibody;
history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment;
not suitable for enrollment at investigator's discretion.
12. IPD Sharing Statement
Citations:
PubMed Identifier
34321836
Citation
Shi Y, Zhang Q, Han X, Qin Y, Ke X, Su H, Liu L, Fu J, Jin J, Feng J, Hong X, Zhang X, Wu D, Jiang B, Dong X. Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma. Chin J Cancer Res. 2021 Jun 30;33(3):405-416. doi: 10.21147/j.issn.1000-9604.2021.03.11.
Results Reference
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A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas
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