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NCT Number: NCT04533581

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Indolent B-cell Non-Hodgkin's Lymphoma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anjo Kosei Hospital, Anjo, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ME-401

Drug

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).

Primary outcomes

  1. 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).

Secondary outcomes

  1. Efficacy of ME-401 as assessed by the duration of response (DOR)

    Time frame: Up to approximately 4 years

  2. Efficacy of ME-401 as assessed by the progression-free survival (PFS)

    Time frame: Up to approximately 4 years

  3. Efficacy of ME-401 as assessed by CR

    Time frame: Up to approximately 4 years

  4. Efficacy of ME-401 as assessed by the Time to treatment failure (TTF)

    Time frame: Up to approximately 4 years

  5. Efficacy of ME-401 as assessed by the objective response rate (ORR)

    Time frame: Up to approximately 4 years

  6. Safety of ME-401 as assessed by the number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to approximately 4 years

  7. 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

  8. Plasma concentration level of ME-401

    Time frame: Up to approximately 4 years

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2020
Registry last updated
Sep 11, 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.

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