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Completed

NCT Number: NCT03985189

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

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information

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Key information

Conditions

Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

[Phase 1 study (DLT evaluation)]

  • Patients aged 20 years or older at the submission of the written informed consent form
  • Patients with relapsed or refractory B-cell NHL
  • Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date.
  • Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors.
  • Patients with ECOG PS 0 or 1.

Exclusion criteria

[Phase 1 study (DLT evaluation)]

  • Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product.
  • Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those.
  • Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test.
  • Patients with active interstitial lung disease or a history thereof.
  • Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401.

Treatment and study plan

ME-401

Drug

[Phase 1 study (DLT evaluation)] ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability.

[Roll over study] 60 mg ME-401 will be administrated on intermittent schedule (1 week on and 3 week off in every 4-week cycle)and will continue until the prescribed mediation in ME-401-004 study is completed or discontinuation criteria are met.

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to approximately 1 year

Secondary outcomes

  1. [Phase 1 study (DLT evaluation)] Plasma concentration level of ME-401

    Time frame: Up to approximately 2 years

  2. [Phase 1 study (DLT evaluation)] Maximum plasma drug concentration (Cmax)

    Time frame: Up to approximately 2 years

  3. [Phase 1 study (DLT evaluation)] Area under the plasma drug concentration time curve (AUC)

    Time frame: Up to approximately 2 years

  4. [Phase 1 study (DLT evaluation)] Terminal half-life (t1/2)

    Time frame: Up to approximately 2 years

  5. [Phase 1 study (DLT evaluation)] Efficacy of ME-401 as assessed by the objective response rate (ORR)

    Time frame: Up to approximately 2 years

  6. [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the duration of response (DOR)

    Time frame: Up to approximately 2 years

  7. [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the progression-free survival (PFS)

    Time frame: Up to approximately 2 years

  8. [Phase 1 study (DLT evaluation)] Efficacy of ME-401 will be assessed by the time to response (TTR)

    Time frame: Up to approximately 2 years

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Japanese Phase 1 Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma and Roll Over Study for Subjects Who Have Participated in ME-401-004 Study

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2019
Registry last updated
Dec 19, 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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