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A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

Primary Purpose

B-Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI301
Rituximab
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. CD20-positive B-cell lymphoma.
  2. 18 years to 65 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  4. Signed an informed consent.
  5. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.

Exclusion Criteria:

  1. Participation in another interventional clinical trial in the past 28 days.
  2. Known allergic reactions against monoclonal antibody or rituximab.
  3. Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
  4. Blood concentration of Rituximab>24ug/ml.
  5. HIV positive patients.
  6. HCV antigen and antibody positive.
  7. Acute and chronic hepatitis B virus infection.

Sites / Locations

  • Beijing cancer hospital
  • Peking University third hospital
  • The 307th Hospital of Military Medical Sciences
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The Third Xiangya Hospital of Central South University
  • Xiangya Hospital of Central South University
  • Jiangsu province people's hospital
  • West China Hospital,Sichuan University
  • Tianjin People's Hospital
  • The First Affiliated Hospital Zhejiang University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBI301

Rituximab

Arm Description

Outcomes

Primary Outcome Measures

AUC0-inf of IBI301 and rituximab

Secondary Outcome Measures

Peak Plasma Concentration (Cmax)
Percentage and absolute value of CD19+
Percentage and absolute value of CD20+ B-cell
Positive rate of ADA
Positive rate of NAb
Safety profiles
Including AE type、incidence rate、severity and drug- related
Area under the plasma concentration versus time curve (AUC)
AUC（0-t） of IBI301 and rituximab

Full Information

First Posted
October 24, 2016
Last Updated
August 30, 2020
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02945215
Brief Title
A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
Official Title
A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBI301
Arm Type
Experimental
Arm Title
Rituximab
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IBI301
Intervention Description
IBI301 375mg/㎡
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab 375mg/㎡
Primary Outcome Measure Information:
Title
AUC0-inf of IBI301 and rituximab
Time Frame
91 days
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Time Frame
91 days
Title
Percentage and absolute value of CD19+
Time Frame
91 days
Title
Percentage and absolute value of CD20+ B-cell
Time Frame
91 days
Title
Positive rate of ADA
Time Frame
91 days
Title
Positive rate of NAb
Time Frame
91 days
Title
Safety profiles
Description
Including AE type、incidence rate、severity and drug- related
Time Frame
up to 1 year
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
91days
Title
AUC（0-t） of IBI301 and rituximab
Time Frame
91 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CD20-positive B-cell lymphoma. 18 years to 65 years. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Signed an informed consent. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy. Exclusion Criteria: Participation in another interventional clinical trial in the past 28 days. Known allergic reactions against monoclonal antibody or rituximab. Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months. Blood concentration of Rituximab>24ug/ml. HIV positive patients. HCV antigen and antibody positive. Acute and chronic hepatitis B virus infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu
Organizational Affiliation
Hematology Hospital of Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing cancer hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University third hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The 307th Hospital of Military Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Haerbin
State/Province
Heilongjiang
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu province people's hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

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