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

Henlius Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: B-cell Lymphomas

Treatments: Drug: HLX01

Study type: Interventional

Funder types: Industry

Identifiers

NCT03218072

HLX01-NHL01

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

HLX01 250 mg/m2

Experimental group

Description:

HLX01 250 mg/m2 administrated intravenously

Treatment:

Drug: HLX01

HLX01 375 mg/m2

Experimental group

Description:

HLX01 375 mg/m2 administrated intravenously

Treatment:

Drug: HLX01

HLX01 500 mg/m2

Experimental group

Description:

HLX01 500 mg/m2 administrated intravenously

Treatment:

Drug: HLX01