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

• Status: Completed
• Trial end date: 2019-10-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Antibodies; Antibodies, Monoclonal; Rituximab

Criteria

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.