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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: B-Cell Lymphoma

Treatments: Drug: Rituximab; Drug: IBI301

Study type: Interventional

Funder types: Industry

Identifiers

NCT02945215

CIBI301A201

Details and patient eligibility

About

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

Enrollment: 181 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 2 patient groups

IBI301

Experimental group

Treatment:

Drug: IBI301

Rituximab

Active Comparator group

Treatment:

Drug: Rituximab