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

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd; Kyowa Kirin Co., Ltd.

Criteria

Inclusion Criteria:

• 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:

• 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.