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

Kyowa Kirin

Status and phase

Completed

Phase 1

Conditions

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

Treatments

Drug: ME-401

Study type

Interventional

Funder types

Industry

Identifiers

NCT03985189

ME-401-K01

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

20+ years old

Volunteers

No 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.