Clinical trial NCT04103905: A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
Official title: A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Tolerability，Pharmacokinetics and Efficacy of MIL62 in Chinese Patients With Relapsed/Refractory CD20+ Malignant B-cell Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CD20-positive B Cell Non-Hodgkin Lymphoma
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.


Eligibility criteria: Inclusion Criteria:

1. Adult patients, \>=18 years of age;
2. Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Life expectancy \>6 months
5. 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
6. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Prior use of any investigational antibody therapy within 3 months of study start
2. Prior use of any anti-cancer vaccine
3. Prior administration of radioimmunotherapy 3 months prior to study entry
4. Central nervous system lymphoma
5. History of other malignancy
6. Evidence of significant, uncontrolled concomitant disease
7. Abnormal laboratory values
8. Patients with progressive multifocalleukoencephalopathy (PML)
9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.

Primary outcomes:
measure: Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
timeFrame: Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response
timeFrame: by the end of Cycle 8 (each cycle is 28 days)
measure: Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Systemic Clearance of MIL62 Under Steady State
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Volume of Distribution Under Steady State (Vss) of MIL62
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Change in Cluster of Differentiation 19 (CD19+) B Cells
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Change in Cluster of Differentiation 20 (CD20+) B Cells
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Percentage of Participants with Positive Anti-Drug Antibodies to MIL62
timeFrame: by the end of Cycle 4 (each cycle is 28 days)
measure: Progression-free Survival (PFS) in the Study
timeFrame: by the end of the follow-up period of the study
measure: Overall Survival (OS) in the Study
timeFrame: by the end of the follow-up period of the study
measure: Duration of response (DoR)
timeFrame: by the end of the follow-up period of the study
measure: Disease control rate (DCR)
timeFrame: by the end of the follow-up period of the study
measure: Participants With Event-Free Survival (EFS)
timeFrame: by the end of the follow-up period of the study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
name: Yuankai Shi
role: PRINCIPAL_INVESTIGATOR
References: