NCT04657965尚未招募早期 1 期
Clinical Trial for the Safety and Efficacy of Sequential of LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies
Zhejiang University1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2021年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies
详细描述
This is a single arm, open-label, single-center study. This study is indicated for LMP1 positive infectious diseases and hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 144 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only applicable to the inclusion criteria of CAEBV
- •Subjects who are diagnosed with CAEBV according to the Okano revised standard proposed by the Japanese Ministry of Health, Labour and Welfare Research Group for the Prevention of Refractory Diseases;
- •All CAEBV patients who have not achieved complete remission, including:
- •Active phase: EBV-DNA level in PBMC is higher than 1×10^2.5 copies/μg DNA, with symptoms and signs of active diseases such as fever, hepatomegaly, splenomegaly, abnormal liver function, decrease of blood three lines, lymphadenopathy, and progressive skin lesions with increased EBV titer in peripheral blood;
- •inactive phase: EBV-DNA level in PBMC is higher than 1×10^2.5 copies/μg DNA, without symptoms and signs of active diseases;
- •The disease has not yet progressed to hematopoietic lymphohistiocytosis (HLH);
- •Only applicable to the inclusion criteria of LMP1-positive ENKTL:
- •According to the 2016 WHO classification criteria for lymphocytic tumors: Subjects diagnosed by histopathology as extranodal NK/T cell lymphoma, nasal type (ENKTL) with LMP1 positive in tumor tissue;
- •R/R ENKTL (meets one of the following prerequisites)
- •Without remission or with progression after receiving second-line or higher-line chemotherapy/chemotherapy + radiotherapy;
- •Primary drug resistance;
- •With recurrence after receiving autologous/allogeneic hematopoietic stem cell transplantation;
- •According to 2014 Lugano standard, there should be at least one evaluable tumor lesion.
- •Only applicable to the inclusion criteria for LMP1-positive HL:
- •According to the 2016 WHO classification criteria for lymphocytic tumors, subjects with Hodgkin lymphoma diagnosed by histopathology (HD) and LMP1 positive in tumor tissue;
- •R/R HD (meets one of the following prerequisites):
- •Without remission or with progression after receiving second-line or higher-line chemotherapy;
- •Primary resistance Drugs;
- •With recurrence after receiving autologous hematopoietic stem cell transplantation;
- •According to the Lugano 2014 standard, there should be at least one evaluable tumor lesion;
- •Only applicable to the inclusion criteria for LMP1-positive PTLD:
- •Only PTLD after hematopoietic stem cell transplantation;
- •According to the 2016 WHO classification criteria for lymphocytic tumors, subjects with PTLD diagnosed by histopathology and LMP1 positive in tumor tissue;
- •Excluding PTLD of early-stage
- •R/R PTLD (meets one of the following prerequisites):
- •Without remission or with progression after receiving rituximab-based standard treatment;
- •Primary drug resistance;
- •According to the Lugano 2014 standard, there should be at least one evaluable tumor lesion
排除标准
- •Subjects with any of the following exclusion criteria were not eligible for this trial:
- •History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Pregnant (or lactating) women;
- •Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- •Active infection of hepatitis B virus or hepatitis C virus;
- •Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- •Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- •Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- •Other uncontrolled diseases that were not suitable for this trial;
- •Patients with HIV infection;
- •Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study
研究组 & 干预措施
Administration of LMP1 CAR T-cells
Experimental
Each subject receive LMP1 CAR T-cells by intravenous infusion
干预措施: LMP1 CAR T-cells (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days after LMP1 targeted CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after LMP1 targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- CAEBV, Relapse rate(RR)(At Month 6, 12, 18 and 24)
- Instrumental Activities of Daily Living (IADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- CAEBV, Event-free survival (EFS)(Up to 2 years after LMP1 CAR-T cells infusion)
- Chronic active EB virus infection (CAEBV), Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- HL, ENKTL, PTLD, OS(Up to 2 years after LMP1 CAR-T cells infusion)
- HL, ENKTL, PTLD, EFS(Up to 2 years after LMP3 CAR-T cells infusion)
- CAEBV，Duration of remission（DOR）(Up to 2 years after LMP1 CAR-T cells infusion)
- Hodgkin's lymphoma(HL), Extranodal NK/T cell lymphoma(ENKTL),Nasal type, Lymphoproliferative disease after hematopoietic stem cell transplantation, (post-HSCT PTLD),Overall response rate (ORR)(At Month 1, 3, 6, 12, 18 and 24)
- Quality of life(At Baseline, Month 1, 3, 6, 9 and 12)
- Activities of Daily Living (ADL) score(At Baseline, Month 1, 3, 6, 9 and 12)
- Hospital Anxiety and Depression Scale (HADS) score(At Baseline, Month 1, 3, 6, 9 and 12)
- CAEBV, Overall survival (OS)(Up to 2 years after LMP1 CAR-T cells infusion)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With R/R AMLAMLNCT05467202Zhejiang University20
招募中
早期 1 期
Clinical Study of CLL1 CAR-T Cells in the Treatment of Hematological MalignanciesAMLNCT05252572Zhejiang University36
Unknown
1 期
CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid MalignanciesLymphomaLeukemiaNCT03121625Hebei Senlang Biotechnology Inc., Ltd.30
尚未招募
早期 1 期
A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells TherapyRelapse Multiple MyelomaNCT04541368Zhejiang University50
Unknown
1 期
CAR-T Cells for Relapsed or Refractory Haematopoietic and Lymphoid MalignanciesLeukemiaMultiple Myeloma of Bone (Diagnosis)LymphomaNCT03312205Hebei Senlang Biotechnology Inc., Ltd.50