Status:
COMPLETED
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
Lead Sponsor:
Beijing Mabworks Biotech Co., Ltd.
Conditions:
CD20-positive B Cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-p...
Eligibility Criteria
Inclusion
- Adult patients, \>=18 years of age;
- Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy \>6 months
- Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments
- Able and willing to provide written informed consent and to comply with the study protocol
Exclusion
- Prior use of any investigational antibody therapy within 3 months of study start
- Prior use of any anti-cancer vaccine
- Prior administration of radioimmunotherapy 3 months prior to study entry
- Central nervous system lymphoma
- History of other malignancy
- Evidence of significant, uncontrolled concomitant disease
- Abnormal laboratory values
- Patients with progressive multifocalleukoencephalopathy (PML)
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
Key Trial Info
Start Date :
February 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04103905
Start Date
February 10 2017
End Date
May 29 2020
Last Update
May 18 2025
Active Locations (1)
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1
Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, China, 100021