Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Medigene AG
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy
研究概览
简要总结
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.
Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
详细描述
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.
Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.
Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.
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
- •Diagnosis of Acute Myeloid Leukemia (AML)
- •Age 18 - 75 years
- •Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
- •WT1 with or without PRAME positivity by qPCR
- •Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
- •Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
- •Informed consent signed prior to any trial related activities
排除标准
- •Patients suitable for allogeneic stem cell transplantation
- •AML M3 (acute promyelocytic leukemia)
- •Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
- •Active immunodeficiency syndromes
- •Concurrent active second malignancy other than non-melanoma skin cancers
- •Clinically relevant autoimmune disease
- •Prior immunotherapy
- •Severe organ dysfunction precluding the apheresis procedure:
- •Creatinine > 200 mmol/l
- •Bilirubin, ALAT and ASAT > 3 x upper normal limit
- •Respiratory insufficiency with pO2 < 60 mmHg
- •Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure > grade II NYHA
- •Recent cerebral hemorrhage
- •Known allergies to substances used in the generation of DCs
- •Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product
- •Use of corticosteroids
- •Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted)
- •Inability to comply with the trial protocol
- •Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial
结局指标
主要结局
Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy
时间窗: 2 years
Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible
时间窗: 2 years
次要结局
- ECOG performance status(2 years)
- Cellular immune responses to applied antigens(2 years)
- Relapse/Progression free survival(2 years)
- Time to progression (TTP).(2 years)
- Control of minimal residual disease (MRD)(2 years)
- Overall survival(2 years)