JPRN-jRCT2080223774已完成1 期
Multi-center, invesitigator-initiated phase 1 study of NY-ESO-1 specific TCR gene transduced T lyphocytes transfuse in patient with refractory adult T-cell leukemia/lymphoma (ATLL) experiencing recurrence after allogenic hematopoietic stem cell transplantation
Dokkyo Medical University, Tokyo University. Nagoya City University, Mie University, Osaka International Cancer Institute, Kyushu University, Nagasaki University, Kagoshima University, Imamura General Hospital0 个研究点目标入组 12 人开始时间: 2018年1月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patient with refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation from his/her relative or from an unrelated individual registerated in Japan Marrow Donor Program (JMDP)
- •2) HLA-A*02:01 or HLA-A*02:06 positive
- •3) NY-ESO-1-expression in tumor-infiltrated tissue (skin, lypph node, etc) or peripheral blood by immunohistochemistry or PCR
- •4) (Only secondary registration) Having a donor who matches eligibility criteria
- •5) ECOG Performance Status, 0 ~ 2
- •6) Age >=20 years on consent
- •7) Life expectancy >= 12 weeks after consent
- •8) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria;
- •T. billirubin < 3xULN
- •AST(GOT), ALT(GPT) < 5xULN
- •Creatinine < 3xULN
- •LVEF >=55%
- •SpO2 >=94%
- •9) (only secondary registration) Completion of TBI-1301-A preparation
- •10) Ability to understand the study contents and to give a written consent at his/her free will
- •1) Original donor of hematopoetic stem cell transplantation
- •2) Age >=20 (20<= Age <=57, in case of an unrelated person coordinated by JMDP) years on consent
- •3) Ability to understand the study contents and to give a written consent at his/her free will
排除标准
- •1) The following serious complications are excluded from the study;
- •Unstable angina, cardiac infarction, or heart failure
- •Uncontrolled diabetes or hypertension
- •Active infection
- •Obvious interstitial pneumonia or lung fibrosis by chest X-ray
- •Active autoimmune disease requiring steroids or immunosuppressive therapy
- •2) Serious hypersensitivity
- •3) Tumor cell invasion into CNS
- •4) Active multiple cancer
- •5) History of serious hypersensitivity reactions to bovine or murine derived substances, human serum albumin, streptomycin sulfate or amphotericin B
- •6) History of hypersensitivity reaction to drugs used in this study
- •7) Recurrence within 30 days after hematopoietic stem cell transplantation
- •8) GVHD >= Grade 3 (based on the guideline given JSHCT)
- •9) Uncontrollable pleural effusion, ascites or pericardial effusion
- •10) Antitumor therapy (chemotherapy, molecular targeted therapy, immunotherapy, radiation therapy, etc.) which are performed or will be performed within 4 weeks prior to the pre-treatment
- •11) Psycological disorder or drug dependency which may have impact on the consent
- •12) Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to at lease 6 months after the transfusion of TBI-1301-A
- •13) Any other inadequacy for this study
- •1) Positvity fo any of HBs antigen, HBV-DNA, HCV antibody, HCV-RNA, HIV antibody, HIV-RNA, serologic test of syphilis and parvovirus B19-DNA
- •2) Psycological disorder or drug dependency which may have impact on the consent
- •3) Any other inadequacy for this study
研究者
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