mRNA Therapy to Restore Lymphatic Flow in Secondary Lymphedema
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety profile of APERNAVEC vector injection during the month following the injection
研究概览
简要总结
Lymphedema is a common complication of breast cancer treatment, affecting approximately a quarter of patients. Those affected can have an uncomfortable, unsightly and sometimes functionally impaired limb prone to episodes of superficial infection. The aetiology and pathophysiology of lymphedema in patients with breast cancer appear to be multifactorial and are still not fully understood.Although conservative treatment techniques can be very successful in controlling symptoms, they do not afford a cure. In this situation of unmet medical need, it is essential to find a new therapeutic solution to treat lymphedema. The approach of the LYMPHARN project is based on dual mRNA strategy delivered by FlashRNA® vector targeting both lymphatic endothelium and surrounding adipose tissue function.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who developed upper limb lymphedema after surgery for breast cancer hormone receptor positive (HR+) more than 5 years,
- •Age> 18 years,
- •Body mass Index (BMI)<40,
- •Stage 2 Lymphedema, moderate (defined by an increase in volume between 20 and 40% compare to the healthy limb),
- •Lymphedema evolving during at least 6 months,
- •Patient who adhere to optimized decongestive therapy, including a compression sleeve worn daily, integrated into an educational care pathway for the management of their lymphedema,
- •Patients information and signed written consent form,
- •Patients affiliated to a social security system.
排除标准
- •HER2+ breast cancer triple positive,
- •Other aggressive breast cancers (including triple negative and inflammatory breast cancer),
- •Active cancer needing chemo- or radio-therapy,
- •Metastatic breast cancer,
- •Bilateral breast cancer,
- •Upper limb peripheral arterial disease ipsilateral to the lymphedema,
- •History of recent (< 3 months) upper limb deep venous thrombosis ipsilateral to the lymphedema,
- •Previous shoulder or orthopedic surgery on lymphedematous arm
- •Any abnormality of the opposite arm (arm without lymphedema),
- •Trophic disorders on the lymphedematous arm,
- •Last episode of cellulitis less than six months,
- •Recurrent cellulitis,
- •Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months or within 5 half-lives of any investigational product Immunosuppressive and anti-inflammatory treatments (topical and anti-inflammatory dermocorticoids and oral corticosteroids) in the 10 days before the injection or within 5 half-lives.
- •Patient under judicial protection or enable to express consent,
- •Females who are or plan to be pregnant or breastfeeding during the course of this study,
- •Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method (hormonal or physical barrier),
- •History of cancer other than breast cancer (excepted basalcell carcinoma),
- •Any acute, chronic, or severe psychiatric condition that may interfere with participation in the study
- •Unstable, clinically significant neurologic, psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- •Known allergy to bovine proteins
- •Vulnerable patients (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code.
研究组 & 干预措施
Experimental group
Patients with secondary lymphedema will be included to receive eight injections of the APERNAVEC (APELIN-VEGF-C FlashRNA® vector) at D0.
干预措施: APERNAVEC (Drug)
结局指标
主要结局
Safety profile of APERNAVEC vector injection during the month following the injection
时间窗: Day 1, Day 2, Day 5, Day 10 and 1 month after injection
To determine the safety profile with the number, the type and the severity of adverse events) occurring
次要结局
- Safety profile of APERNAVEC vector injection during 6 months following the injection(1 month, 3 months and 6 months after injection)
- Feasibility of the procedures(Day 0 (injection visit))
- local and systemic inflammatory reaction following injections(Day 0 (post injection), Day 1, Day 2, Day 10, 1 month, 3 months and 6 months after injection)
- Efficacy of injections(Day 1, Day 2, Day 10, 1 month, 3 months and 6 months after injection)
- Pharmacokinetic of the APERNAVEC vector in the blood(Day 0, 4 hours post injection, 24h (Day 1), 48h (Day 2), Day 10 and1 month after injection)
- plasma biobanking(Day 0, Day 10 and 1 month after injection)