A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas

B-cell Lymphomas Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218072
• Other study ID #: HLX01-NHL01
• Status: Completed
• Phase: Phase 1
• Start date: May 4, 2014
• Est. completion date: January 31, 2015

Study information

• Verified date: May 2022
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 31, 2015
• Est. primary completion date: January 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Lymphomas
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• HLX01
a potential rituximab biosimilar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs	The type, severity and incidence of adverse events	From First infusion to Day 90
Primary	SAEs	Thetype, severity and incidence of SAEs	From First infusion to Day 90
Secondary	AUC0-inf	Area under the serum concentration-time curve from time 0 extrapolated to infinity	From First administration to Day 90
Secondary	Cmax	Maximum serum concentration	From First administration to Day 90
Secondary	t1/2	terminal half-life	From First administration to Day 90
Secondary	CD19 positive B cells	The count of CD19 positive in peripheral blood	From First administration to Day 90
Secondary	CD20 positive B cells	The count of CD20 positive in peripheral blood	From First administration to Day 90
Secondary	Antidrug antibodies of HLX01	The concentration of anti-HLX01 in serum	From First administration to Day 90