Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 65 years old (inclusive)
• You have been diagnosed with cystic fibrosis (CF)
• Your lung function test result (a breathing test called FEV1) falls between 50% and 100% of the expected value
• Your blood oxygen level is at least 94% when measured by a finger clip device while breathing normal room air
• Your CF has been stable and you have not needed any new type of treatment in the last 3 months, as confirmed by the study doctor

Who may not be able to join:

• You have had any change to your regular lung treatments (including antibiotics) in the past 28 days (note: certain inhaled breathing medications may be allowed if taken within the past 2 weeks — confirm with trial site)
• You have coughed up a significant amount of blood (more than about ¼ cup or 10 teaspoons in a day) in the past 12 weeks
• You have a lung infection with a specific bacteria called Mycobacterium abscessus that is causing your lung health to decline more quickly
• You are currently being treated for an active lung infection caused by Burkholderia cenocepacia or Burkholderia dolosa bacteria
• You have had an organ transplant or a bone marrow/blood cell transplant in the past
• You have a history of significant liver scarring (cirrhosis), with or without related blood pressure complications
• You have a history of high blood pressure in the lungs (pulmonary hypertension)
• You have a history of heart damage, known heart artery disease, or a condition affecting the heart muscle
• You currently have an active fungal infection, certain blood, lung, or bladder infections, significant liver or kidney problems, or a viral infection such as HIV or hepatitis B or C that requires new treatment started within the past 30 days
• You have a history of a specific allergic lung condition called allergic bronchopulmonary aspergillosis (ABPA) (confirm with trial site)
• You have diabetes that is not well controlled, shown by a blood sugar marker (HbA1c) above 9% at your screening visit
• You have significantly abnormal blood test results at your screening visit
• You have any other medical condition or abnormal test result that the study doctor believes could make it unsafe for you to take part
• You have taken part in another clinical trial or received an experimental treatment within the past 30 days (or longer, depending on the treatment — confirm with trial site)
• You have previously received any gene therapy treatment
• You have a known allergy or sensitivity to SP-101, doxorubicin, or any of their ingredients

Important: Always verify eligibility with the trial site directly before applying.