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

Kyowa Kirin Co., Ltd0 个研究点目标入组 14 人开始时间: 2019年6月5日最近更新: 2023年10月17日

适应症

试验速览

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•- 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.
•- Patients who treated with ME-401 and acieved response of SD or better by IRRC tumor assessment in ME-401-004 study.

•- 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.
•- Patients who have experienced adverse events related to ME-401 and been considered to be ineligible to participate in this study by physician.
•- Patients with diseases not suitable for treatment with ME-401, for example, active interstitial lung disease and inflammatory bowel disease.
•- Patients who have been treated or prevented CMV within the past 28 days.
•- Patients who plan to participate in other clinical trials while receiving ME-401 in this study.

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