Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune®) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- TC Biopharm
- 入组人数
- 10
- 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 potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.
详细描述
This is an open-label, safety and efficacy, escalating dose, single arm study on 9 adult subjects (3 cohorts) and 3+3 design will be used. HLA typed patients and potential blood-related donors will be screened for comorbidities. Suitably matched or haploidentical family donors will be selected according to protocol specified criteria and institutional guidelines of participating site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
- •Relapsed or refractory AML
- •AML relapse after intensive chemotherapy OR
- •AML relapse after allogeneic HCT OR
- •AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR
- •No response to at least 4 cycles of low intensity therapy
- •AML refractory to 2 cycles of induction chemotherapy
- •Presence of > 5% of blasts in bone marrow or peripheral blood smear
- •Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
- •Considered suitable for lymphodepleting chemotherapy
- •Age 18 years up to the age of 70 (≤ 70)
- •Life expectancy of at least 3 months
- •Karnofsky performance status ≥ 50%
- •Available related HLA-haploidentical or HLA-matched donor
- •Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.
- •Patient able to understand and sign written informed consent
排除标准
- •Uncontrolled infections
- •Renal insufficiency: creatinine > 180 μmol/L or on dialysis
- •Heart failure: EF < 40%
- •Respiratory insufficiency: oxygen therapy required at inclusion in the study
- •Significant liver impairment: bilirubin > 50 μmol/L, AST or ALT > 4 times normal upper limit
- •Treatment with bisphosphonates (2 months before start)
- •Active autoimmune disease or GvHD
- •Pregnant or breastfeeding
- •Patient of fertile age not using two-barrier method of birth control.
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 OmnImmune® 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 OmnImmune® 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
- Overall Survival (OS) [Efficacy](24 months post-treatment)
- Quality of Life (QoL)(24 months post-treatment)
- Number of patients reaching Complete Remission (CR) [Efficacy](24 months post-treatment)