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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02945215

Enrollment

181

Registered

2016-10-26

Start date

2016-12-13

Completion date

2019-10-16

Last updated

2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Lymphoma

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

Interventions

DRUGIBI301

IBI301 375mg/㎡

DRUGRituximab

Rituximab 375mg/㎡

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
AUC0-inf of IBI301 and rituximab	91 days

Secondary

Measure	Time frame	Description
Percentage and absolute value of CD19+	91 days	—
Percentage and absolute value of CD20+ B-cell	91 days	—
Positive rate of ADA	91 days	—
Peak Plasma Concentration (Cmax)	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	—
AUC（0-t） of IBI301 and rituximab	91 days	—
Positive rate of NAb	91 days	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026