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

NCT03218072 | Completed Phase 1

• 1 other identifier: HLX01-NHL01
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

B-cell Lymphomas

Outcome Measures

Primary Outcomes (2)

• AEs

  The type, severity and incidence of adverse events

  From First infusion to Day 90

• SAEs

  Thetype, severity and incidence of SAEs

  From First infusion to Day 90

Secondary Outcomes (6)

• AUC0-inf

  From First administration to Day 90

• Cmax

  From First administration to Day 90

• t1/2

  From First administration to Day 90

• CD19 positive B cells

  From First administration to Day 90

• CD20 positive B cells

  From First administration to Day 90

Study Arms (3)

HLX01 250 mg/m2

EXPERIMENTAL

HLX01 250 mg/m2 administrated intravenously

Drug: HLX01

HLX01 375 mg/m2

EXPERIMENTAL

HLX01 375 mg/m2 administrated intravenously

Drug: HLX01

HLX01 500 mg/m2

EXPERIMENTAL

HLX01 500 mg/m2 administrated intravenously

Drug: HLX01

Interventions

HLX01 DRUG

a potential rituximab biosimilar

HLX01 250 mg/m2; HLX01 375 mg/m2; HLX01 500 mg/m2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Related 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 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.

  PMID: 34321836 RESULT

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 14, 2017
• Study Start: May 4, 2014
• Primary Completion: January 31, 2015
• Study Completion: January 31, 2015
• Last Updated: May 9, 2022

Record last verified: 2022-05