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

B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945215
• Other study ID #: CIBI301A201
• Status: Completed
• Phase: Phase 1
• Start date: December 13, 2016
• Est. completion date: October 16, 2019

Study information

• Verified date: June 2020
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 16, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• IBI301
IBI301 375mg/?
• Rituximab
Rituximab 375mg/?

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing	Beijing
China	Peking University third hospital	Beijing	Beijing
China	The 307th Hospital of Military Medical Sciences	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Harbin Medical University Cancer Hospital	Haerbin	Heilongjiang
China	The First Affiliated Hospital Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jiangsu province people's hospital	Nanjing	Jiangsu
China	Tianjin People's Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf of IBI301 and rituximab		91 days
Secondary	Peak Plasma Concentration (Cmax)		91 days
Secondary	Percentage and absolute value of CD19+		91 days
Secondary	Percentage and absolute value of CD20+ B-cell		91 days
Secondary	Positive rate of ADA		91 days
Secondary	Positive rate of NAb		91 days
Secondary	Safety profiles	Including AE type?incidence rate?severity and drug- related	up to 1 year
Secondary	Area under the plasma concentration versus time curve (AUC)		91days
Secondary	AUC(0-t) of IBI301 and rituximab		91 days