COMPLETED

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis

Conditions

Persistent Infection Cystic Fibrosis Pseudamonas auriginosa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunctive therapy to standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in people with cystic fibrosis (pwCF). The main questions the study aims to answer are: * Are single doses of CMTX-101 IV infusion safe and tolerated * What is the pharmacokinetic (PK) profile of single doses of CMTX-101 * Do single doses of CMTX-101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs)

Official Title

A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Antibiotics In People With Cystic Fibrosis Chronically Infected With Pseudomonas Aeruginosa

Quick Facts

Study Start:2024-06-24

Study Completion:2025-11-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06159725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults ≥18 years of age at the time of screening. 2. If enrolled in the CFF Patient Registry, must provide registry information. 3. Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines. 4. For participants on modulator therapy, they must be on a stable dose of modulator therapy for at least 3 months. 5. Willing and capable of providing induced sputum for evaluation at defined study timepoints. 6. Positive P. aeruginosa growth of ≥104 CFU/gram from a sample of induced sputum at the screening visit. 7. FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening. 8. Currently receiving inhaled antibiotic therapy, either tobramycin or aztreonam alone, or as part of CAT. At least one 28-day cycle completed within 8 weeks prior to screening visit. 9. Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin test during screening and agree to use an effective method of contraception for the duration of the study and for 4 months after the last infusion of study drug. A female participant is considered of childbearing potential unless postmenopausal or surgically sterilized and at least 3 months has passed since sterilization procedure. Female surgical sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, or bilateral oophorectomy. A female participant is considered postmenopausal if she has had spontaneous amenorrhea for at least 2 years with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). 10. Male participants with a female partner must use a medically accepted contraceptive regimen during his participation in the study and for 4 months after study drug infusion. 11. Male participants must agree to abstain from sperm donation through 4 months after study drug administration. 12. Capable of providing informed consent. 13. Capable and willing to complete all study visits and perform all procedures required by the protocol.	1. Body mass index (BMI) \<14 at screening and baseline. 2. Has a known history or evidence of human immunodeficiency virus (HIV) infection or chronic hepatitis B screening. 3. Tests positive for hepatitis C virus (HCV) RNA at screening. 4. Pulmonary exacerbation within 28 days of baseline. 5. Requirement for continuous (24 hour/day) oxygen supplementation; periodic use is permitted. 6. Participation in smoking or vaping activity in the last 6 months. 7. History of, or planned, organ transplantation. 8. Elevated liver function tests obtained at screening. 1. ALT \>5 × ULN or AST \>5 × ULN, or 2. Total bilirubin \>3 × ULN or Total bilirubin \>1.5 × ULN combined with either ALT \>3 × ULN or AST \>3 × ULN. ULN reflects local laboratory ranges. 9. Greater than 5 ml of hemoptysis on one occasion or \>30 mL of hemoptysis in a 24-hour period within 28 days of baseline. 10. Infection with other more pathogenic organisms such as Mycobacterium abscessus or Burkholderia spp., where the investigator feels that the participant either is not or will not remain clinically stable throughout the duration of the study. 11. Acute clinical illness requiring a new (oral, parenteral, or inhaled) antibiotic(s) ≤30 days prior to the baseline visit. Does not include chronic suppressive medications or cyclic dosing medications such as inhaled antibiotics. 12. Women who are pregnant, planning to become pregnant during the study period or for 4 months following last infusion of study drug, or breastfeeding. 13. Active treatment of any mycobacterial or fungal organisms ≤30 days prior to baseline visit. Chronic treatment for suppression of fungal populations is allowable. 14. Anticipated need to change chronic (either inhaled or oral) antibiotic regimens during the study period. Participants must agree to maintain their current chronic antibiotic regimen from the screening visit for the duration of the follow-up period (approximately 30 days). 15. Known allergy to any component of the study drug. 16. Participant with an estimated glomerular filtration rate \<60 mL/min/1.73 m2. 17. Any significant finding that, in the opinion of the investigator, would make it unsafe for the participant to participate in this study or would not be in the best interest of the participant. 18. Enrolled in an interventional clinical study within ≤60 days of the baseline visit, or participating in a clinical study while enrolled in this clinical study (inclusive of vaccine studies). 19. Currently or previously enrolled in this study.

Inclusion Criteria

Exclusion Criteria

1. Adults ≥18 years of age at the time of screening.
2. If enrolled in the CFF Patient Registry, must provide registry information.
3. Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines.
4. For participants on modulator therapy, they must be on a stable dose of modulator therapy for at least 3 months.
5. Willing and capable of providing induced sputum for evaluation at defined study timepoints.
6. Positive P. aeruginosa growth of ≥104 CFU/gram from a sample of induced sputum at the screening visit.
7. FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening.
8. Currently receiving inhaled antibiotic therapy, either tobramycin or aztreonam alone, or as part of CAT. At least one 28-day cycle completed within 8 weeks prior to screening visit.
9. Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin test during screening and agree to use an effective method of contraception for the duration of the study and for 4 months after the last infusion of study drug. A female participant is considered of childbearing potential unless postmenopausal or surgically sterilized and at least 3 months has passed since sterilization procedure. Female surgical sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, or bilateral oophorectomy. A female participant is considered postmenopausal if she has had spontaneous amenorrhea for at least 2 years with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms).
10. Male participants with a female partner must use a medically accepted contraceptive regimen during his participation in the study and for 4 months after study drug infusion.
11. Male participants must agree to abstain from sperm donation through 4 months after study drug administration.
12. Capable of providing informed consent.
13. Capable and willing to complete all study visits and perform all procedures required by the protocol.

1. Body mass index (BMI) \<14 at screening and baseline.
2. Has a known history or evidence of human immunodeficiency virus (HIV) infection or chronic hepatitis B screening.
3. Tests positive for hepatitis C virus (HCV) RNA at screening.
4. Pulmonary exacerbation within 28 days of baseline.
5. Requirement for continuous (24 hour/day) oxygen supplementation; periodic use is permitted.
6. Participation in smoking or vaping activity in the last 6 months.
7. History of, or planned, organ transplantation.
8. Elevated liver function tests obtained at screening.
1. ALT \>5 × ULN or AST \>5 × ULN, or
2. Total bilirubin \>3 × ULN or Total bilirubin \>1.5 × ULN combined with either ALT \>3 × ULN or AST \>3 × ULN. ULN reflects local laboratory ranges.
9. Greater than 5 ml of hemoptysis on one occasion or \>30 mL of hemoptysis in a 24-hour period within 28 days of baseline.
10. Infection with other more pathogenic organisms such as Mycobacterium abscessus or Burkholderia spp., where the investigator feels that the participant either is not or will not remain clinically stable throughout the duration of the study.
11. Acute clinical illness requiring a new (oral, parenteral, or inhaled) antibiotic(s) ≤30 days prior to the baseline visit. Does not include chronic suppressive medications or cyclic dosing medications such as inhaled antibiotics.
12. Women who are pregnant, planning to become pregnant during the study period or for 4 months following last infusion of study drug, or breastfeeding.
13. Active treatment of any mycobacterial or fungal organisms ≤30 days prior to baseline visit. Chronic treatment for suppression of fungal populations is allowable.
14. Anticipated need to change chronic (either inhaled or oral) antibiotic regimens during the study period. Participants must agree to maintain their current chronic antibiotic regimen from the screening visit for the duration of the follow-up period (approximately 30 days).
15. Known allergy to any component of the study drug.
16. Participant with an estimated glomerular filtration rate \<60 mL/min/1.73 m2.
17. Any significant finding that, in the opinion of the investigator, would make it unsafe for the participant to participate in this study or would not be in the best interest of the participant.
18. Enrolled in an interventional clinical study within ≤60 days of the baseline visit, or participating in a clinical study while enrolled in this clinical study (inclusive of vaccine studies).
19. Currently or previously enrolled in this study.

Contacts and Locations

Study Locations (Sites)

University of Alabama, Birmingham

Birmingham, Alabama, 35294

United States

Stanford University

Palo Alto, California, 94304

United States

University of California, San Francisco

San Franciso, California, 94143

United States

National Jewish Health

Denver, Colorado, 80206

United States

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803

United States

St Luke's Sleep Medicine and Research Center

Boise, Idaho, 83702

United States

Cystic Fibrosis Institute

Northfield, Illinois, 60093

United States

University of Kansas

Kansas City, Kansas, 66160

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

New York Medical College

Hawthorne, New York, 10532

United States

Lenox Hill Hospital

New York, New York, 10075

United States

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

PennState Health

Hershey, Pennsylvania, 17003

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Vanderbilt University

Nashville, Tennessee, 37235

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Virginia Commonwealth University

Richmond, Virginia, 23219

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Clarametyx Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-24

Study Completion Date2025-11-14

Study Record Updates

Study Start Date2024-06-24

Study Completion Date2025-11-14

Terms related to this study

Keywords Provided by Researchers

Pseudamonas auriginosa

Additional Relevant MeSH Terms

Persistent Infection
Cystic Fibrosis