Actively Recruiting
LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
Led by Steven Hays, MD · Updated on 2026-05-14
30
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
S
Steven Hays, MD
Lead Sponsor
O
OrphAI Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: * Is LAM-001 safe in these patients? * Is LAM-001 effective in slowing BOS progression? Participants will: * Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks * Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period * Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination * Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.
CONDITIONS
Official Title
LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years old
- Recipient of a double lung transplant at least 12 months before study entry
- Clinically diagnosed chronic lung allograft dysfunction with BOS phenotype, including all of the following:
- BOS defined as screening FEV1 between 85-51% of baseline by two highest FEV1 measures at least 3 weeks apart
- Diagnosis within 12 months of screening
- Persistent FEV1 decline lasting more than 30 days
- Receiving stable standard immunosuppression with prednisone, mycophenolate or azathioprine, and tacrolimus or cyclosporine for at least 4 weeks before screening
- No oral sirolimus or everolimus treatment for at least 4 weeks prior to screening
- Stable enough to undergo routine post-transplant bronchoscopy with BAL and biopsy if needed
- Able to understand the study purpose and risks
- Provided written informed consent or assent and able to comply with study requirements
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to entry
- Women of childbearing potential who are sexually active must use highly effective contraception during the study and for 90 days after treatment ends
- Women of childbearing potential must avoid breastfeeding and egg donation during the study and for 90 days after treatment ends
- Male participants must use condoms during sex with women of childbearing potential and for 90 days after treatment ends
- Male participants must avoid sperm donation during the study and for 90 days after treatment ends
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control during the study
- Any condition or abnormality that might compromise patient safety or data quality as judged by the investigator
- Previous lung retransplant or currently listed for retransplant
- Confirmed other causes of lung function loss such as acute infection, acute rejection, or restrictive allograft syndrome
- Acute antibody-mediated rejection at screening; stable patients with donor-specific antibodies may be eligible
- Active acute bacterial, viral, or fungal infection unresolved for at least 4 weeks prior to screening; stable chronic infections may be eligible
- Mechanical ventilation within 12 weeks before randomization
- Resting oxygen saturation below 89% on room air or use of supplemental oxygen at rest at screening
- Functional airway stenosis with ongoing symptoms at screening or baseline
- Known allergy to sirolimus or everolimus
- Enrolled in another investigational BOS trial
- Chronic renal failure with serum creatinine > 2.5 mg/dL or needing dialysis
- Liver disease with bilirubin > 3 times normal or transaminases > 2.5 times normal
- Active cancer within past 2 years except treated localized skin cancers
- History of malignancy likely to cause significant disability or need major treatment within 6 months
- Severe lactose allergy (lactose intolerance allowed)
- Uncontrolled high blood pressure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
S
Steven Hays, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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