Trials / Unknown
UnknownNCT04304040
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma
A Phase I/IIa Study on Dose-escalation and Extension of Recombinant Humanized Type II CD20 Monoclonal Antibody MIL62 Injection Combined With BTK Inhibitor Orelabrutinib in the Treatment of Recurrent/Refractory CD20+B-cell Lymphoma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orelabrutinib | BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days. |
| DRUG | Recombinant humanized monoclonal antibody MIL62 injection | Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days. |
Timeline
- Start date
- 2020-07-28
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2020-03-11
- Last updated
- 2024-02-07
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04304040. Inclusion in this directory is not an endorsement.