Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants with Severe/Adverse Events as a Measure of Safety.
研究概览
简要总结
This study aims to evaluate the safety and efficacy of autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
详细描述
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, screening and registration to the trial, apheresis, γδT cells preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatment and follow-up. The study will evaluate the safety and efficacy of the autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should sign informed consent form voluntarily.
- •Gender unlimited, age ≥ 18 years old.
- •Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma(PTCL) expect for γδT lymphoma.
- •Patients had an evaluable imaging lesion of at least greater than 1.5 cm (except CLL).
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-
- •Adequate bone marrow function as defined by：Absolute neutrophil count (ANC) >1000/mm3；Absolute lymphocyte count (ALC) ≥300/mm3；Platelet ≥50000/mm3；Hemoglobin >8.0g/dl.
- •Adequate end organ function as defined by: Total bilirubin ≤ 2 x upper limit of normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 60ml/min.
- •Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
排除标准
- •Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- •Active central nervous system (CNS) lymphoma; Patients with symptoms of CNS disease must undergo lumbar puncture and brain nuclear magnetic resonance to exclude CNS lymphoma.
- •Patients receiving chemotherapy within 2 weeks prior to γδT cell infusion, with the following exceptions:
- •Pretreatment chemotherapy prescribed by the protocol
- •In order to prevent CNS intrathecal chemotherapy (should be stopped 1 week before γδT cell therapy)
- •Other exploratory combined medications
- •Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
- •Active chronic hepatitis B or hepatitis C virus infection, active cytomegalovirus (CMV), EBV infection.
- •Major surgery that was evaluated by the investigator as unsuitable for inclusion within 4 weeks prior to screening.
- •History of other malignant tumors, with the following exceptions
- •Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)
- •Cured situ carcinoma (e.g. cervical carcinoma)
- •Localized prostate cancer with radiotherapy or surgery
- •Patients with a history of malignant tumors, but the disease has been cured for ≥2 years
- •Patient's cardiac function meets any of the following conditions
- •Left ventricular ejection fraction (LVEF) ≤45%
- •Class III or IV heart failure according to the NYHA Heart Failure Classifications
- •QTcB>450 msec
- •Other cardiac disease that investigators judge is not suitable for enrollment
- •History of epilepsy or other active central nervous system disorders.
- •Inoculated live vaccine within 6 weeks before screening.
- •Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia).
- •Patients are allergic to cytokines.
- •Expected survival < 12 weeks.
- •Participated in any other interventional clinical trial within three months.
- •Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.
研究组 & 干预措施
Autologous γδT cells
Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions, single infusion intravenously at a target dose of 1~2×10e9 γδT cells (constant dose).
干预措施: Autologous γδT cells (Biological)
结局指标
主要结局
Number of Participants with Severe/Adverse Events as a Measure of Safety.
时间窗: 15 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Overall response rate (ORR)
时间窗: 28 days after infusion of γδT cells
Rate of complete remission (CR) and partial remission (PR).
次要结局
- Duration of remission (DOR)(15 months)
- Disease control rate (DCR)(15 months)
- Overall survival (OS)(15 months)
- Progression free survival (PFS)(15 months)
- Time to response(TTR)(15 months)
研究者
Zou Dehui
Chief physician
Institute of Hematology & Blood Diseases Hospital, China