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NCT Number: NCT02945215

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing cancer hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IBI301

Drug

IBI301 375mg/㎡

Rituximab

Drug

Rituximab 375mg/㎡

Primary outcomes

  1. AUC0-inf of IBI301 and rituximab

    Time frame: 91 days

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 91 days

  2. Percentage and absolute value of CD19+

    Time frame: 91 days

  3. Percentage and absolute value of CD20+ B-cell

    Time frame: 91 days

  4. Positive rate of ADA

    Time frame: 91 days

  5. Positive rate of NAb

    Time frame: 91 days

  6. Safety profiles

    Time frame: up to 1 year

    Including AE type、incidence rate、severity and drug- related

  7. Area under the plasma concentration versus time curve (AUC)

    Time frame: 91days

  8. AUC（0-t） of IBI301 and rituximab

    Time frame: 91 days

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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