Trials / Completed
CompletedNCT03332121
B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma
Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection(B001)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.
Detailed description
Phase I dose escalation study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | B001 | 4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77 |
Timeline
- Start date
- 2018-03-22
- Primary completion
- 2020-11-30
- Completion
- 2021-02-28
- First posted
- 2017-11-06
- Last updated
- 2021-11-15
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03332121. Inclusion in this directory is not an endorsement.