EUCTR2018-003977-93-FR进行中（未招募）1 期
International, multicenter, randomized, double-blinded, placebo-controlled study of Recombinant Interleukin-7 (CYT107) to restore absolute lymphocyte counts (ALC) in patients with Sepsis - IRIS-7 C
RevImmune0 个研究点目标入组 40 人开始时间: 2019年3月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.A written, signed informed consent, by the patient or the patient’s legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing study participation
- •2.Men and women ages = 18 – 85 years of age
- •Participants with an absolute lymphocyte count (ALC) = 900 cells/mm3, at two time points at least twelve hours apart, following diagnosis of vasopressor dependent sepsis and,
- •a.the second time point should not be performed earlier than 48 hours after sepsis diagnosis,
- •b.study drug treatment initiation is required no later than 120 hours (up to 5 days) after the last qualifying ALC = 900 cells/mm3 measure, and
- •c.the average value of the two qualifying ALC counts will serve as a baseline to express the percent increase at day 29, or at hospital discharge.
- •3.Patients in the ICU with onset of vasopressor dependent sepsis defined as hypotension requiring treatment with any vasopressor(s) for at least 6 hours to maintain a systolic pressure = 90 mmHg or a mean arterial pressure =65 mmHg AND at least 1 of the 2 organ dysfunction criteria below:
- •a.Acute respiratory failure defined as the need for invasive mechanical ventilation for at least 24 hours to support pulmonary function
- •b.Acute kidney injury defined as creatinine > 2.0 mg/dL (based on new abnormal result following onset of sepsis) OR urine output < 0.5 mL/kg/hr for > 4 hours despite adequate fluid resuscitation. In the presence of pre-existing impairment of renal function (defined as a serum creatinine concentration >2 times the upper limit of the normal reference range prior to the onset of sepsis), the patient must meet the other organ dysfunction criteria.
- •4.Anticipated hospital duration of up to approx. three weeks after initiating study drug treatment to allow 6 study drug administrations (Days 18 or 19 would be final dose)
- •5.This study permits the re-enrollment of a participant who may have been discontinued as a pre- treatment screen failure and/or prior to study drug treatment.
- •6.Age and reproductive status:
- •a.Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment
- •b.Women must not be breastfeeding
- •c.Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with CYT107 plus 5 half-lives of CYT107 (the terminal half-life of CYT107 is up to 2 days) plus 30 days (duration of ovulatory cycle) for a total of 2 months post-treatment completion.
- •d.Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with CYT107 plus 5 half-lives of CYT107 plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.
- •e.Azospermic males are exempt from contraceptive requirements.
- •f.WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements but still must undergo pregnancy testing as described in this section.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Cancer with current chemotherapy or radiotherapy (receipt of chemotherapy or radiotherapy for cancer within the last 6 weeks). All patients with current, or history of, hematologic malignancy (including, but not limited to, ALL, AML, CLL, CML, etc.) or lymphoma will be excluded, regardless of receipt of recent chemotherapy
- •2.Patients with minimal chance of survival and life expectancy less than 3-5 days as defined by an APACHE II score of = 35 at time of consideration for study eligibility
- •3.Patients with history or current evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn’s disease, autoimmune hepatitis, Wegener’s etc.
- •4.Patients who have received solid organ transplant or bone marrow transplant.
- •5.Patients with active or a history of acute or chronic lymphocytic leukemia
- •6.AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
- •7.Known history of chronic HBV infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization or HBV DNA > 100 IU/mL
- •8.Known history of infection with HCV and currently undergoing treatment for HCV infections or has detectable HCV RNA
- •9.History of splenectomy
- •10.Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary
- •spherocytosis, Gaucher’s Disease, and autoimmune hemolytic anemia
- •11.Participation in another investigational interventional study testing a drug or a medical device within the last 3 months prior to study entry
- •12.Patients receiving immunosuppressive drugs, e.g., TNF-alpha inhibitors, for any reason, or systemic corticosteroids other than hydrocortisone at a dose of 300 mg/day
- •13.Patients receiving concurrent immunotherapy or biologic agents; including growth factors, cytokines and interleukins other than the study medication : IL-2, Interferons a, ß and ?, GM-CSF, G-CSF, HIV vaccines, immunosuppressive drugs, hydroxyurea, immunoglobulins, adoptive cell therapy
- •14.Prior exposure to IL 7 or other drugs specifically targeting T cells
- •15.Presence of an advanced directive to withhold or withdraw life-sustaining treatment, DNR order or no CPR order, or comfort measures only order
- •16.Patients for whom prognosis is poor and source control of septic event is considered unlikely per the clinical and research teams.
- •17.Patients under guardianship
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