Actively Recruiting
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
Led by Spirovant Sciences, Inc. · Updated on 2024-11-25
15
Participants Needed
4
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.
CONDITIONS
Official Title
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females, age 18 to 65 years at Screening Visit, inclusive
- Diagnosis of cystic fibrosis
- ppFEV1 value between 50-100% (inclusive)
- Resting oxygen saturation 9% on room air by pulse oximetry
- Clinically stable cystic fibrosis disease as assessed by the Investigator and not requiring any new class of interventional treatment within the last 3 months prior to Screening
You will not qualify if you...
- Any change in established pulmonary treatment (including antibiotics) within 28 days prior to Screening Visit, except inhaled beta-agonists within 2 weeks prior
- Clinically significant episode of hemoptysis (>50 mL or c cup or 10 teaspoons per day) within 12 weeks prior to dosing
- Lung infection with Mycobacterium abscessus associated with rapid decline in pulmonary status
- Currently receiving treatment for active lung infection with Burkholderia cenocepacia or Burkholderia dolosa
- History of solid organ or hematological transplantation
- History of clinically significant cirrhosis with or without portal hypertension
- History of pulmonary hypertension
- History of cardiotoxicity, known coronary artery disease, or existing cardiomyopathy
- Current active fungal infection, acute blood, lung, or bladder infection, significant hepatic or renal dysfunction, or viral infection requiring new therapy within 30 days prior to Screening
- History of allergic bronchopulmonary aspergillosis (ABPA)
- Uncontrolled diabetes mellitus with hemoglobin A1c >9% at Screening
- Clinically significant laboratory abnormalities at Screening
- Any medical condition or abnormal laboratory result interfering with safe study completion
- Received any investigational products within 30 days or 5 therapeutic half-lives before Screening
- Previously received any gene therapy agent
- Known sensitivity to SP-101, doxorubicin, or its excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
2
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Columbia University
New York, New York, United States, 10032
Actively Recruiting
4
Hospital at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Spirovant.ClinicalTrials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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