B-cell Lymphomas
Conditions
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.
Interventions
DRUGHLX01
a potential rituximab biosimilar
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs | From First infusion to Day 90 | The type, severity and incidence of adverse events |
| SAEs | From First infusion to Day 90 | Thetype, severity and incidence of SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 | From First administration to Day 90 | terminal half-life |
| CD19 positive B cells | From First administration to Day 90 | The count of CD19 positive in peripheral blood |
| AUC0-inf | From First administration to Day 90 | Area under the serum concentration-time curve from time 0 extrapolated to infinity |
| Antidrug antibodies of HLX01 | From First administration to Day 90 | The concentration of anti-HLX01 in serum |
| CD20 positive B cells | From First administration to Day 90 | The count of CD20 positive in peripheral blood |
| Cmax | From First administration to Day 90 | Maximum serum concentration |
Outcome results
None listed