Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
研究概览
简要总结
This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.
详细描述
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation；
- •Age criteria: 18-65 years;
- •Weight criteria: > 40kg;
- •Organ function criteria:
- •Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN;
- •Life expectancy of at least 4 months;
- •ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
- •Patients able to understand and sign written informed consent.
排除标准
- •GVHD (graft versus host disease) ≥ grade Ⅱ；
- •Thrombotic microangiopathy；
- •Posttransplant lymphoproliferative disorders；
- •Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
- •Patients with chronic diseases that require treatment with immune agents or hormones;
- •Suffering from systemic autoimmune disease or immunodeficiency disease;
- •Systemic use of steroids;
- •Allergic constitution;
- •Hemorrhagic disease or coagulation disorders;
- •Patients participating in other clinical trials within 30 days prior to enrollment;
- •Patients receiving radiotherapy within 4 weeks prior to enrollment;
- •Pregnant or breastfeeding women;
- •According to the researcher's judgment, the patient has other unsuitable conditions.
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
时间窗: Day 28 after completion of treatment
Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
时间窗: Day 28 after completion of treatment
Safety of γδ T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
次要结局
- Number of patients reaching Complete Remission (CR) [Efficacy](12 months post-treatment)
- Quality of Life (QoL)(12 months post-treatment)
- Overall Survival (OS) [Efficacy](12 months post-treatment)
- Persistence of γδ T cell(Before treatment and up to 3 months after treatment)
研究者
Han weidong
Professor
Chinese PLA General Hospital