JPRN-jRCTc031190101已完成2 期
A clinical trial on the efficacy of combination therapy with immune-cell therapy(Alpha beta T-cell therapy) and immune check point inhibitor for malignant tumor - Combination therapy with immune-cell therapy and immune check point inhibitor
Takimoto Rishu0 个研究点目标入组 4 人开始时间: 2019年9月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
A total of 4 patients with malignant tumors were enrolled in this clinical study from June 2020 to May 2022. One PR, 1 SD and 1 PD were observed. Survival time was 39.8 months in PR and 15.9 months in SD patinet. Due to the COVID-19 outbreak, few patients participated in the study. The study has been terminated as it will be difficult to involve more patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •A patient MUST:
- •1) Be diagnosed with relapsed or advanced malignant tumor.
- •2) Have a measurable lesion of tumor.
- •3) Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
- •4) Be administered immune check point inhibitor and immune-cell therapy within 4 weeks at the clinic.
- •5) Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
- •6) Provide agreement of the attending doctor to participate in this study.
- •7) Have a backup hospital in the case of emergency.
- •8) Provide written consent to participate in this study.
排除标准
- •A patient MUST NOT:
- •1) Have a positive result of HIV antibody.
- •2) Have a T cell-, NK cell-derived malingnant lymphoma/leukemia (in the case of activated immune-cell therapy).
- •3) Be post allogenic bone marrow transplantation.
- •4) Have a history of a serious adverse event due to immune check point inhibitor.
- •5) Be a female who is pregnant, lactating, or with a possibility of pregnancy.
- •6) A patient who is judged as inadequate for enrolment by doctors is excluded
研究者
相似试验
已完成
4 期
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity StatinCardiovascular DiseasesNCT04080310Seoul National University Bundang Hospital270
Unknown
4 期
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque PsoriasisChronic Plaque PsoriasisNCT00707070Universita di Verona100
已完成
不适用
Home Treatment With Carfilzomib in Patients With Multiple MyelomaMultiple MyelomaNCT05620238Thomas Lund9
进行中（未招募）
2 期
Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M NeuroblastomaNeuroblastomaNCT03503864Yang Li80
已完成
2 期
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT03662542Janssen Research & Development, LLC214