NCT05643729暂停1 期
A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of ZofinTM for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of Zofin
研究概览
简要总结
A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).
详细描述
Total of 20 adult patients will be chosen from population of adults between the age of 40 to 80 diagnosed with COPD to be randomized to 1 of 2 treatment arms including IV infusion of Zofin or IV infusion on sterile saline.
The subjects will be followed for 12 months to demonstrate safety and efficacy of Zofin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study will be double blinded such that neither the patients nor the researchers will know who is getting a placebo and who is getting the treatment. Only product manufacturing staff will be un-blinded.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who can understand and are able to provide informed consent.
- •Subject with moderate to severe COPD with normal cardiac, liver and renal function
- •Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7
- •Subject must have a post-bronchodilator FEV1 percent predicted value <50%
- •Subject must have a RV/TLC ratio of > 40%
- •Subject must be either a non-smoker or an ex-smoker, with a cigarette smoking history of ≥ 10 packs per year.
- •Subject must have abstained from nicotine products for at least six months prior to enrollment in the study.
- •Subject must be available for all specified assessments at the study site through the completion of the study.
- •Subject must have oxyhemoglobin saturation on room air at rest equal or greater than 88% without oxygen
- •Subject must be reasonably able to return for multiple follow-up visits.
- •Adequate venous access
- •For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment.
- •Any male subject must agree to use contraceptives and not donate sperm during the study.
排除标准
- •Subject with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the infusion or complete the study
- •Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
- •Subject has been diagnosed with a pulmonary disease other than COPD (e.g. asthma, pulmonary, fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease)
- •Subject has been diagnosed with α1-Antitrypsin deficiency
- •Subject has a body mass index greater than 42 kg/m2
- •Subject has or had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
- •Subject has or had exacerbation of COPD requiring hospitalization within 12 weeks of enrollment in the study.
- •Subject has initiated pulmonary rehabilitation within 12 weeks of enrollment in the study
- •Subject uses or used prednisone (or equivalent dose of another corticosteroid) within 12 weeks of enrollment in the study
- •Subject has evidence or history of malignancy
- •Subject has evidence or history of autoimmune disorders independent of COPD
- •Subject is pregnant or breast-feeding
- •Subject with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. Subject with clinically significant bronchiectasis.
- •Subject received an experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment.
- •Subject is unable to complete all the testing required for the study
- •Subject who is on immunosuppressive medications.
- •Subject who is unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit.
- •Subject with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to infusion.
- •Active listing (or expected future listing) for transplant of any organ.
- •Be a solid organ transplant recipient. This does not include prior cell-based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting. Have a history of organ or cell transplant rejection.
- •History of drug abuse (illegal "street" drugs) except noninhalation use of marijuana (If it is legal use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs withinthe past 24 months. Use of inhalation marijuana will be an exclusion criterion.
- •Subject with untreated HIV infection. However, patients can be enrolled if they have been treated for HIV and test negative for HIV viral load but still test positive for antibodies.
研究组 & 干预措施
Group 1: Zofin
Experimental
Group 1 Treatment Arm (10 subjects): Zofin + Standard of care (SOC) Ten subjects will receive 1 mL of Zofin on Day 0, Day 4, and Day 8, containing 1-5 x 10^11 particles/ml. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside. In addition to Zofin all subjects in this trial will receive SOC throughout the study period.
干预措施: Zofin (Drug)
Group 2: Placebo
Placebo Comparator
Group 2 Control Arm (10 subjects): Placebo + SOC Ten subjects will receive placebo on Day 0, Day 4, and Day 8, containing 101 mL of sterile saline at subject's bedside. In addition to placebo all subjects in this trial will receive SOC throughout the study period.
干预措施: Placebo (Other)
结局指标
主要结局
Safety of Zofin
时间窗: day 0 to 12 months
To monitor the frequency and severity of adverse events
次要结局
- FEV1(Screen, day 4, day 8, 4 months, 8 months and 12 months)
- TNF-α(Day 0, Day14, 4 months, 8 months, and 12 months)
- FVC(Screen, day 4, day 8, 4 months, 8 months and 12 months)
- D-Dimer(Day 0, Day14, 4 months, 8 months, and 12 months)
- FEV1 to FVC ratio(Screen, day 4, day 8, 4 months, 8 months and 12 months)
- Peak VO2(Screen, 4 months, and 12 months)
- Dynamic Hyperinflation(Screen, 4 months, and 12 months)
- CRP(Day 0, Day14, 4 months, 8 months, and 12 months)
- FEF25-75(Screen, day 4, day 8, 4 months, 8 months and 12 months)
- Lung Volume Changes(Screen, day 4, day 8, 4 months, 8 months and 12 months)
- DLCO(Screen, day 4, day 8, 4 months, 8 months and 12 months)
- HU of CT Scan(Screen and 12 months)
- % air in lung on CT Scan(Screen and 12 months)
- CPET(Screen, 4 months, and 12 months)
- Pulmonary Exacerbation(Screening through 12 months)
- IL-1(Day 0, Day14, 4 months, 8 months, and 12 months)
- CAT Assessment(Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months)
- Fibrinogen(Day 0, Day14, 4 months, 8 months, and 12 months)
- SF-36 ot SGRQ(Screen, 14 days, 1.5 months, 4 months, 8 months, and 12 months)
研究者
研究点 (1)
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