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

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

NCT03985189•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Aomori Prefectural Central Hospital

Aomori, Japan

Kyushu University Hospital

Fukuoka, Japan

Okayama University Hospital

Okayama, Japan

Key Dates

Start Date

April 29, 2019

Primary Completion Date

January 15, 2025

Completion Date

January 15, 2025

Last Updated

December 19, 2025

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Interventions

ME-401

DRUG