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Completed

NCT Number: NCT04103905

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

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.

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Key information

Conditions

CD20-positive B Cell Non-Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

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

Secondary outcomes

  1. Percentage of Participants With Best Overall Response

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

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

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

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

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

  4. Systemic Clearance of MIL62 Under Steady State

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

  5. Volume of Distribution Under Steady State (Vss) of MIL62

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

  6. Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State

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

  7. Change in Cluster of Differentiation 19 (CD19+) B Cells

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

  8. Change in Cluster of Differentiation 20 (CD20+) B Cells

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

  9. Percentage of Participants with Positive Anti-Drug Antibodies to MIL62

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

  10. Progression-free Survival (PFS) in the Study

    Time frame: by the end of the follow-up period of the study

  11. Overall Survival (OS) in the Study

    Time frame: by the end of the follow-up period of the study

  12. Duration of response (DoR)

    Time frame: by the end of the follow-up period of the study

  13. Disease control rate (DCR)

    Time frame: by the end of the follow-up period of the study

  14. Participants With Event-Free Survival (EFS)

    Time frame: by the end of the follow-up period of the study

Sponsors and collaborators

Lead sponsor

Beijing Mabworks Biotech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 26, 2019
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.