Back to search results

LAM-001 for Bronchiolitis Obliterans Syndrome After Lung Transplant

This study is testing LAM-001, given as an inhaled dry powder, for people who have developed bronchiolitis obliterans syndrome (BOS) after a lung transplant. BOS is a type of chronic rejection that can happen after a lung transplant. Researchers want to see if LAM-001 is safe and if it can slow down the progression of BOS. You might be able to join if you are over 18, had a double lung transplant at least a year ago, and have a recent diagnosis of BOS. The main way they will measure success is by looking at the change in your lung function (FEV1) after 48 weeks. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive either LAM-001 or a placebo (an inactive substance) daily. It plans to enroll 30 participants.
What's involved
You would inhale either LAM-001 or placebo daily for 48 weeks. You would also attend 10 study visits (in-person and telehealth), undergo lung function tests, bronchoscopy, lab tests, physical exams, and do weekly home spirometry monitoring.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 48 weeks, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06018766

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

Recruiting
PHASE2Ages 18+InterventionalTreatment
Steven Hays, MD
~30 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:LAM-001Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
% change in FEV1 from baseline
Measured over 48 week

Conditions

Bronchiolitis Obliterans Syndrome
Chronic Lung Allograft Dysfunction
Lung Transplantation

Explore related trials

Bronchiolitis Obliterans SyndromeChronic Lung Allograft Dysfunction

NCT06018766

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Steven Hays, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Steven Hays, MD
[email protected]
415-336-4141
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age \> 18 years old
Recipient of a double pulmonary allograft at least 12 months before study entry
Subjects with clinically diagnosed CLAD-BOS phenotype (all 3 required)
BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.
Diagnosis within 12 months of screening visit.
FEV1 decline is persistent as defined by decline sustained for \> 30 days.
Currently receiving Standard Immunosuppression. This is defined as a combination of 3 medications including Prednisone, Mycophenolate or Azathioprine, and Tacrolimus or Cyclosporine. The dosing should be stable for 4 weeks prior to screening.
Absence of oral sirolimus or everolimus treatment for at least 4 weeks prior to screening based on the half-life and resolution of the tissue effects
Stable enough to enable routine post-transplant bronchoscopy with BAL and biopsy when indicated
Capable of understanding the purposes and risks of the study
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry
Women of childbearing potential if sexually active must agree to using highly effective contraception during study and for 90 days after discontinuation of study treatment
Women of childbearing potential must refrain from breast feeding or donating eggs for the duration of the study and for 90 days after the last dose of study treatment
Male participants must agree to use a condom during sexual contact with a female of childbearing potential while participating in the study and for 90 days following discontinuation of investigational product use
Male participants must refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment

Exclusion

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Patients with re-transplantation or currently listed for re-transplantation
Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition), etc.
Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable donor-specific antibodies (DSA) levels at the Screening Visit are eligible for the study
Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the investigator are eligible.
Mechanical ventilation within 12 weeks prior to the randomization
Patient has baseline resting oxygen saturation of \< 89% on room air or use of supplemental oxygen at rest at screening
Evidence of functional airway stenosis (i.e., bronchomalacia/ tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and/or Baseline Visit
Known hypersensitivity to sirolimus or everolimus
Currently enrolled in another investigational trial for obstructive chronic lung allograft dysfunction (BOS)
Patients with chronic renal failure, defined as serum creatinine \> 2.5 mg/dL at screening, or requiring chronic dialysis
Patients with liver disease and serum bilirubin \> 3-fold upper limit of normal range or transaminases \> 2.5 upper limit of normal range
Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, except for treated, localized basal and squamous cell carcinomas
Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized skin cancer.
History of severe allergic reaction to lactose (patients with lactose intolerance are eligible)
Patients with uncontrolled hypertension

What this trial measures

  • % change in FEV1 from baseline48 week

    Patient's % change in FEV1 from baseline at 48 weeks or termination of treatment, whichever is earlier