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

Phase 1

Completed

• Conditions: B-Cell Lymphoma
• Interventions: Drug: IBI301; Drug: Rituximab

• Registration Number: NCT02945215
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Study Start: 2016-12-13
• Primary Completion: 2019-03-21
• Study Completion: 2019-10-16
• Status Verified: 2020-06
• Last Update Submitted: 2020-08-30
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI301	IBI301	-
Rituximab	Rituximab	-

Primary Outcome Measures

Name	Time	Method
AUC0-inf of IBI301 and rituximab	91 days

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Beijing cancer hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Harbin Medical University Cancer Hospital; 🇨🇳 Haerbin, Heilongjiang, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Jiangsu province people's hospital; 🇨🇳 Nanjing, Jiangsu, China

Tianjin People's Hospital; 🇨🇳 Tianjin, Tianjin, China

West China Hospital,Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The 307th Hospital of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China

Peking University third hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China