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

August 30, 2020 updated by: Innovent Biologics (Suzhou) Co. Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Cancer Hospital
      • Beijing, Beijing, China
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • The 307th Hospital of Military Medical Sciences
    • Heilongjiang
      • Haerbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
    • Hunan
      • Changsha, Hunan, China
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province People's Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital,Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rituximab
Drug: Rituximab
Rituximab 375mg/㎡
EXPERIMENTAL: IBI301
Drug: IBI301
IBI301 375mg/㎡

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-inf of IBI301 and rituximab
Time Frame: 91 days
91 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 91 days
91 days
Percentage and absolute value of CD19+
Time Frame: 91 days
91 days
Percentage and absolute value of CD20+ B-cell
Time Frame: 91 days
91 days
Positive rate of ADA
Time Frame: 91 days
91 days
Positive rate of NAb
Time Frame: 91 days
91 days
Safety profiles
Time Frame: up to 1 year
Including AE type、incidence rate、severity and drug- related
up to 1 year
Area under the plasma concentration versus time curve (AUC)
Time Frame: 91days
91days
AUC（0-t） of IBI301 and rituximab
Time Frame: 91 days
91 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 13, 2016

Primary Completion (ACTUAL)

March 21, 2019

Study Completion (ACTUAL)

October 16, 2019

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (ESTIMATE)

October 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI301A201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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