This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells).
The primary objective of this study is to evaluate the preliminary within-participant changes of SORT-COPD (SMS cells), in suspension, delivered to the lung as an aerosolized mist via a vibrating mesh nebulizer, on respiratory health status in participants with moderate to severe chronic obstructive pulmonary disease.
Adult >18 yrs old (inclusive).
Is a woman of nonchildbearing potential (WONCBP) OR
Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method from screening until 30 days after the last dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at Screening and on Day 1, prior to administration of study intervention.
Previous or current diagnosis of COPD-G, COPD-D, COPD-I, COPD-A, or COPD-U; asthma, congestive heart failure, bronchiectasis, tuberculosis, obliterative bronchiolitis, or diffuse panbronchiolitis.
Previous or current history of respiratory failure other than due to COPD (e.g., restrictive lung disease, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, CMV pneumonitis, cystic fibrosis, asbestosis, silicosis, or farmer's lung disease), or detection of any of these conditions through screening CT scanning.
History of COVID-associated pneumonia with hypoxemic respiratory failure in the 12 weeks prior to screening.
Current use, or use within 21 days of screening, of systemic or inhaled corticosteroids. Participants on inhaled corticosteroids or combined inhaled therapies can be included; however, they must schedule inhaled therapies 12 hours prior to dosing IP and 12 hours post-dosing IP.
Sequential
Stem cells
Biological/VaccineThe suspension of Small Mobile Stem (SMS) cells will be placed into a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. Participants with moderate to severe chronic obstructive pulmonary disease (COPD) will breathe in the mist containing the SMS cells through a mouthpiece. The treatment will be given at the study site on Days 1, 3, and 6. Each treatment will contain 2.4 billion SMS cells and will take approximately 30 minutes to complete. This is a Phase 1b/2a study designed to evaluate the safety, tolerability, and potential effects of SMS cells in people with moderate to severe COPD.
Adverse events (AEs)
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) graded using CTCAE Version 6.0, and incidence of treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Phase 1b: Dose-limiting toxicities (DLTs)
Incidence of DLTs and and participant stopping-rule events during Phase 1b safety review period prior to Phase 2a expansion
Number of Participants With Clinically Significant Changes From Baseline in Hematology Laboratory Parameters
Number of participants with at least one clinically significant change from baseline in hematology laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Hematology assessments include protocol-specified parameters such as hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Participants with one or more clinically significant hematology abnormalities will be counted once for this outcome measure.
Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Laboratory Parameters
Number of participants with at least one clinically significant change from baseline in serum chemistry laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Serum chemistry assessments include protocol-specified measures of renal function, hepatic function, electrolytes, glucose, and other chemistry parameters. Participants with one or more clinically significant serum chemistry abnormalities will be counted once for this outcome measure.
Spirometry
Within-participant absolute change from baseline in post-bronchodilator Forced Expiratory Volume in One Second (FEV1), measured in liters (L), performed according to ATS/ERS standards
Spirometry
Within-participant change from baseline in post-bronchodilator FEV1 z-score, calculated using GLI Global reference equations
Spirometry
Within-participant change from baseline in Percent Predicted FEV1 (ppFEV1), measured in percentage points and calculated using GLI Global reference equations
Spirometry
Within-participant change from baseline in Forced Vital Capacity (FVC), measured in liters (L), performed according to ATS/ERS standards
This trial is not recruiting at the moment. You can still explore other options:
