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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218072
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

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

Condition or disease Intervention/treatment Phase
B-cell Lymphomas Drug: HLX01 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 4, 2014
Actual Primary Completion Date : January 31, 2015
Actual Study Completion Date : January 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: HLX01 250 mg/m2
HLX01 250 mg/m2 administrated intravenously
Drug: HLX01
a potential rituximab biosimilar

Experimental: HLX01 375 mg/m2
HLX01 375 mg/m2 administrated intravenously
Drug: HLX01
a potential rituximab biosimilar

Experimental: HLX01 500 mg/m2
HLX01 500 mg/m2 administrated intravenously
Drug: HLX01
a potential rituximab biosimilar




Primary Outcome Measures :
  1. AEs [ Time Frame: From First infusion to Day 90 ]
    The type, severity and incidence of adverse events

  2. SAEs [ Time Frame: From First infusion to Day 90 ]
    Thetype, severity and incidence of SAEs


Secondary Outcome Measures :
  1. AUC0-inf [ Time Frame: From First administration to Day 90 ]
    Area under the serum concentration-time curve from time 0 extrapolated to infinity

  2. Cmax [ Time Frame: From First administration to Day 90 ]
    Maximum serum concentration

  3. t1/2 [ Time Frame: From First administration to Day 90 ]
    terminal half-life

  4. CD19 positive B cells [ Time Frame: From First administration to Day 90 ]
    The count of CD19 positive in peripheral blood

  5. CD20 positive B cells [ Time Frame: From First administration to Day 90 ]
    The count of CD20 positive in peripheral blood

  6. Antidrug antibodies of HLX01 [ Time Frame: From First administration to Day 90 ]
    The concentration of anti-HLX01 in serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT03218072    
Other Study ID Numbers: HLX01-NHL01
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin