A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas

NCT04103905 | Completed Phase 1

• 1 other identifier: MIL62-CT01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

CD20-positive B Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study

  Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period

Secondary Outcomes (14)

• Percentage of Participants With Best Overall Response

  by the end of Cycle 8 (each cycle is 28 days)

• Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62

  by the end of Cycle 4 (each cycle is 28 days)

• Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State

  by the end of Cycle 4 (each cycle is 28 days)

• Systemic Clearance of MIL62 Under Steady State

  by the end of Cycle 4 (each cycle is 28 days)

• Volume of Distribution Under Steady State (Vss) of MIL62

  by the end of Cycle 4 (each cycle is 28 days)

Study Arms (1)

MIL62

EXPERIMENTAL

Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection

Interventions

Recombinant Humanized Monoclonal Antibody MIL62 Injection DRUG

The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (200mg, 400mg, 800mg, 1000mg, and 1500mg, respectively) based on the sequence of inclusion. Each patient received an intravenous infusion of MIL62 on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days.

MIL62

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Yuankai Shi

  Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 26, 2019
• Study Start: February 10, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 29, 2020
• Last Updated: May 18, 2025

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)