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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02945215 |
Recruitment Status :
Completed
First Posted : October 26, 2016
Last Update Posted : September 1, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-Cell Lymphoma | Drug: IBI301 Drug: Rituximab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 181 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 13, 2016 |
Actual Primary Completion Date : | March 21, 2019 |
Actual Study Completion Date : | October 16, 2019 |

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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945215
China, Beijing | |
Beijing cancer hospital | |
Beijing, Beijing, China | |
Peking University third hospital | |
Beijing, Beijing, China | |
The 307th Hospital of Military Medical Sciences | |
Beijing, Beijing, China | |
China, Heilongjiang | |
Harbin Medical University Cancer Hospital | |
Haerbin, Heilongjiang, China | |
China, Henan | |
The First Affiliated Hospital of Zhengzhou University | |
Zhengzhou, Henan, China | |
China, Hunan | |
The Third Xiangya Hospital of Central South University | |
Changsha, Hunan, China | |
Xiangya Hospital of Central South University | |
Changsha, Hunan, China | |
China, Jiangsu | |
Jiangsu province people's hospital | |
Nanjing, Jiangsu, China | |
China, Sichuan | |
West China Hospital,Sichuan University | |
Chengdu, Sichuan, China | |
China, Tianjin | |
Tianjin People's Hospital | |
Tianjin, Tianjin, China | |
China, Zhejiang | |
The First Affiliated Hospital Zhejiang University | |
Hangzhou, Zhejiang, China | |
The Second Affiliated Hospital of Zhejiang University School of Medicine | |
Hangzhou, Zhejiang, China |
Principal Investigator: | Lugui Qiu | Hematology Hospital of Chinese Academy of Medical Sciences |
Responsible Party: | Innovent Biologics (Suzhou) Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT02945215 |
Other Study ID Numbers: |
CIBI301A201 |
First Posted: | October 26, 2016 Key Record Dates |
Last Update Posted: | September 1, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |