A Safety Study of CellProtect, an Autologous ex Vivo Expanded and Activated Natural Killer (NK) Cell Product, in Patients With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
Multiple Myeloma (MM) is a lethal disease and at present no available treatment method seems to prevent the disease from progressing or relapsing in the long term. NK cells have a relatively high cytotoxic capacity and an anti tumour effect, suggesting a potential as a treatment of MM.This is a phase I, first-in-human, therapeutic exploratory study, where no benefits for the patients can be guaranteed. However, the theoretical implication is that the infused cells may have a positive antitumour effect for the participating individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Above 18 years of age
- •MM diagnosis (stage I-III according to the International Staging System)
- •Eligible for, and willing to undergo, high dose chemotherapy and ASCT
- •Measurable monoclonal immunoglobulins
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy of at least three months
排除标准
- •Non-secretory MM
- •Malignancy, other than MM, treated with chemotherapy or radiation within the past six months
- •Blood donation or other significant blood loss within three months from screening
- •Any physical condition or laboratory results that contraindicate a blood donation to be performed within four weeks from screening
- •Any physical condition or laboratory results that require the chemotherapy to start before there is available slot for blood donation
- •Known or suspected allergic reactions to any ingredient of the IP
- •Diagnosis or indication of any active autoimmune disease, such as Rheumatoid Arthritis, Inflammatory Bowel Disease, Systemic Lupus Erythematosis or Multiple Sclerosis
- •Uncontrolled or severe cardiovascular disease, such as myocardial infarction within six months from screening, heart failure (class III or IV according to New York Heart Association), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis
- •Poorly controlled hypertension
- •Poorly controlled Diabetes Mellitus, type I or II
- •Diagnosis or indication of any clinically relevant renal disease
- •Diagnosis or indication of any clinically relevant hepatic disease
- •Ongoing infection that is considered chronic
- •Known or suspected drug or alcohol abuse, within 12 months from screening
- •Pregnant, trying to become pregnant, or nursing
- •Lack of, or unreliable contraceptive method, as judged by the Investigator
- •Medical history or any abnormal physical finding that is clinically relevant and could interfere with the safety or objectives of the study, as judged by the Investigator
- •Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
研究组 & 干预措施
Autologous NK cells
The investigation product is a cell suspension based on ex vivo expanded NK cells from patients with MM. The treatment is strictly autologous. The IP is given as three infusions with escalating doses.
Mode of administration Intravenous infusions. Dose levels
- First infusion; 5x10^6 cells/kg body weight
- Second infusion; 50x10^6 cells/kg body weight
- Third infusion; 100x10^6 cells/kg body weight
干预措施: autologous NK cells (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: From first dose of study treatment up until six months from last infusion.
Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SEAS)(including IARS). TEAEs are defined as AEs that develop, worsen (according to the Investigators opinion), or bedome serious during the treatment period.
次要结局
- Changes on serum monoclonal immunoglobulin levels as a marker of efficacy(From date of screening through study completion, up until six months from last infusion)
- Changes on serum free light chain levels as a marker of efficacy(From date of screening through study completion, up until six months from last infusion)
- Effect of CellProtect on plasma cell fraction in bone marrow(From date of screening up until one month from last infusion)
- Changes on urine monoclonal immunoglobulin levels as a marker of efficacy(From date of screening through study completion, up until six months from last infusion)
- Response assessment as defined by the International Myeloma Working Group uniform response criteria(From date of screening up until six months from last infusion)
研究者
Hareth Nahi
Principal Investigator
Karolinska University Hospital