Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

September 5, 2025 updated by: Kyowa Kirin Co., Ltd.

A Japanese Phase 2 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan
        • Akita University Hospital
      • Aomori, Japan
        • Aomori Prefectural Central Hospital
      • Chiba, Japan
        • Chiba Cancer Center
      • Fukuoka, Japan
        • Kyushu University Hospital
      • Fukuoka, Japan
        • National Hospital Organization Kyushu Medical Center
      • Kagoshima, Japan
        • Kagoshima University Hospital
      • Kumamoto, Japan
        • National Hospital Organization Kumamoto Medical Center
      • Kyoto, Japan
        • Japanese Red Cross Kyoto Daini Hospital
      • Okayama, Japan
        • Okayama University Hospital
    • Aichi-ken
      • Anjo, Aichi-ken, Japan
        • Anjo Kosei Hospital
      • Nagoya, Aichi-ken, Japan
        • Aichi Cancer Center Hospital
      • Nagoya, Aichi-ken, Japan
        • Japanese Red Cross Nagoya Daini Hospital
      • Nagoya, Aichi-ken, Japan
        • National Hospital Organization Nagoya Medical Center
    • Chiba
      • Kamogawa, Chiba, Japan
        • Kameda Medical Center
    • Ehime
      • Matsuyama, Ehime, Japan
        • National Hospital Organization Shikoku Cancer Center
    • Gunma
      • Maebashi, Gunma, Japan
        • Gunma University Hospital
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Chugoku Central Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Hokkaido University Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan
        • Ishikawa Prefectural Central Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan
        • Tohoku University Hospital
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan
        • Kurashiki Central Hospital
    • Osaka
      • Sayama, Osaka, Japan
        • Kindai University Hospital
      • Suita, Osaka, Japan
        • Osaka University Hospital
    • Saitama
      • Hidaka, Saitama, Japan
        • Saitama Medical University International Medical Center
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Tokyo Metropolitan Komagome Hospital
      • Chuo-ku, Tokyo, Japan
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Japan
        • The Cancer Institute Hospital of Jfcr
    • Tottori
      • Yonago, Tottori, Japan
        • Tottori University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 20 years or older at the submission of the written informed consent form
  • Patients that have undergone therapy after at least 2 prior systemic therapies (anti-CD20 Ab, chemo, and so on) for relapsed or refractory B-cell NHL
  • Patients who have not undergone phosphatidylinositol 3-kinase (PI3K) inhibitors to date
  • Patients who have not undergone Bruton's tyrosine kinase (BTK) inhibitors to date
  • Patients with Eastern Cooperative Oncology Group Performance status (ECOG PS) "0 or 1"

Exclusion Criteria:

  • Patients with relapsed or refractory B-cell NHL who is categorized into Small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), Lymphoplasmacytic lymphoma (LPL) by WHO classification
  • Patients who have been histologically confirmed FL Grade 3b transformation from Follicular lymphoma (FL) to an aggressive lymphoma at least once
  • Patients with lymphomatous involvement of the central nervous system
  • Patients with uncontrolled clinically significant illness
  • Patients with active interstitial lung disease or a history thereof

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ME-401
Drug: ME-401
In the first 2 cycles (1 cycle is 28 days), subjects will be administered 60 mg of ME-401 orally once a day on a continuous schedule (CS). After that, subjects will be administered 60 mg of ME-401 orally once a day for the first 7 days, followed by rest for 21 days on an intermittent schedule (IS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 2 years
ORR is measured as the proportion of subjects achieving the best response rating of complete response (CR) or partial response (PR) prior to first progressive disease (PD).
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of ME-401 as assessed by the duration of response (DOR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Efficacy of ME-401 as assessed by the progression-free survival (PFS)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Efficacy of ME-401 as assessed by CR
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Efficacy of ME-401 as assessed by the objective response rate (ORR)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Safety of ME-401 as assessed by the time to occurrence of adverse event of special interest (AESI)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Plasma concentration level of ME-401
Time Frame: Up to approximately 4 years
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2020

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-401-K02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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