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New pill shows promise for Hard-to-Treat blood cancer in early japanese study

NCT ID NCT03985189

Disease control Sponsor: Kyowa Kirin Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new oral drug called ME-401 in 14 Japanese patients with a slow-growing form of non-Hodgkin's lymphoma that had returned or stopped responding to prior treatments. The main goals were to check the drug's safety, find the right dose, and see how the body processes it. Researchers also offered a roll-over option for continued treatment and safety monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ME-401 (a PI3K inhibitor taken orally)
What this could lead to
If successful, this could lead to a new treatment option for Japanese patients with a type of blood cancer that has come back or not responded to other therapies.
What could go wrong
This is a very early, small Phase 1 trial with only 14 participants, focused on safety and dosing. It is not designed to prove effectiveness, and the drug may cause side effects or fail in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Apr 2019

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

indolent B-cell non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory indolent B-cell non-Hodgkin's lymphoma

Contacts and locations

Locations

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-0814, Japan

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550, Japan

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677, Japan