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Persistent InfectionPhase 1/2NCT06159725

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

A Phase 1/2 study testing CMTX-101 in people with Persistent Infection and Cystic Fibrosis, run by Clarametyx Biosciences, Inc. at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Infection, Cystic Fibrosis
What is being tested?
CMTX-101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
23 sitesUnited States
Study dates
24 Jun 2024to 14 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥18 years of age at the time of screening.
  • If enrolled in the CFF Patient Registry, must provide registry information.
  • Confirmed CF diagnosis based on current CF Foundation (CFF)-sponsored guidelines.
  • For participants on modulator therapy, they must be on a stable dose of modulator therapy for at least 3 months.
  • Willing and capable of providing induced sputum for evaluation at defined study timepoints.
  • Positive P. aeruginosa growth of ≥104 CFU/gram from a sample of induced sputum at the screening visit.
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  • FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening.
  • 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.
  • 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).
  • Effective methods of contraception include (a) abstinence, (b) partner vasectomy, (c) intrauterine devices, (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
  • 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.
  • Acceptable methods of contraception for male participants include condoms with spermicide, surgical sterilization of the participant (i.e., vasectomy) at least 26 weeks before screening, or sexual abstinence (i.e., refraining from heterosexual intercourse) if that is the preferred and usual lifestyle of the participant.
  • Males with infertility documentation are not required to use contraception.
  • Male participants must agree to abstain from sperm donation through 4 months after study drug administration.
  • Capable of providing informed consent.
  • Capable and willing to complete all study visits and perform all procedures required by the protocol.

Who cannot join

  • Body mass index (BMI) <14 at screening and baseline.
  • Has a known history or evidence of human immunodeficiency virus (HIV) infection or chronic hepatitis B screening.
  • Tests positive for hepatitis C virus (HCV) RNA at screening.
  • Pulmonary exacerbation within 28 days of baseline.
  • Requirement for continuous (24 hour/day) oxygen supplementation; periodic use is permitted.
  • Participation in smoking or vaping activity in the last 6 months.
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  • History of, or planned, organ transplantation.
  • Elevated liver function tests obtained at screening.
  • ALT >5 × ULN or AST >5 × ULN, or
  • 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.
  • Greater than 5 ml of hemoptysis on one occasion or >30 mL of hemoptysis in a 24-hour period within 28 days of baseline.
  • 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.
  • 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.
  • Women who are pregnant, planning to become pregnant during the study period or for 4 months following last infusion of study drug, or breastfeeding.
  • Active treatment of any mycobacterial or fungal organisms ≤30 days prior to baseline visit. Chronic treatment for suppression of fungal populations is allowable.
  • 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).
  • Known allergy to any component of the study drug.
  • Participant with an estimated glomerular filtration rate <60 mL/min/1.73 m2.
  • 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.
  • 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).
  • Currently or previously enrolled in this study.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294

  • St Luke's Sleep Medicine and Research Center

    Boise, Idaho, 83702

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

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

    Cleveland, Ohio, 44106

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • National Jewish Health

    Denver, Colorado, 80206

  • New York Medical College

    Hawthorne, New York, 10532

  • PennState Health

    Hershey, Pennsylvania, 17003

  • University of Kansas

    Kansas City, Kansas, 66160

  • Vanderbilt University

    Nashville, Tennessee, 37235

  • Lenox Hill Hospital

    New York, New York, 10075

  • Cystic Fibrosis Institute

    Northfield, Illinois, 60093

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California, San Francisco

    San Franciso, California, 94143

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

About this study

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

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)
Being tested
CMTX-101, Placebo
Keywords
Pseudamonas auriginosa
Medical subject headings
Persistent Infection, Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMTX-101Drug

    CMTX-101 is a humanized monoclonal antibody administered as a single IV infusion over approximately 60 minutes.

  • PlaceboDrug

    Placebo is normal saline administered as a single IV infusion over approximately 60 minutes.

Study groups in NCT06159725
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching placebo, 100mL normal saline
Receives: Drug: Placebo
5 mg/kg CMTX-101Experimental5mg/kg CMTX-101 in 100mL normal saline
Receives: Drug: CMTX-101
30 mg/kg CMTX-101Experimental30 mg/kg CMTX-101 in 100mL normal saline
Receives: Drug: CMTX-101
15 mg/kg CMTX-101Experimental15 mg/kg CMTX-101 in 100mL normal saline
Receives: Drug: CMTX-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101

    Primary objective

    Measured: Day 1 to Day 28

  2. Number and % of participants experiencing serious adverse events following a single IV infusion of CMTX-101

    Primary objective

    Measured: Day 1 to Day 28

Secondary outcomes (9)

  1. Assess the CMax - observed maximum plasma concentration determined by ELISA following a single IV infustion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  2. Assess the TMax - time to reach maximum concentration curve following a single IV infusion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  3. Assess the AUC0-∞ Area under the concentration time curve from zero to infinite time following a single IV infusion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  4. Assess the Terminal phase elimination rate determined by ELISA following a single IV infusion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  5. Assess the Terminal elimination half- determined by ELISA following a single IV infusion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  6. Assess the Apparent total body clearance (CL/F) determined by ELISA following a single IV infusion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  7. Assess the Apparent volume distribution (Vx/F) determined by ELISA following a single IV infustion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  8. Evaluate the immunogenicity of CMTX-101 as measured by anti-drug antibodies (ADA) determined by the electrochemiluminescence assay following a single IV infustion of CMTX-101

    Secondary objective

    Measured: Day 1 to Day 35

  9. Assess the apparent reduction in pulmonary P. auriginosa burden as measured by quantitative microbial culture of sputum

    Secondary objective

    Measured: Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2023
  2. Study start24 Jun 2024
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1 is a single-group, unblinded study Part 2 is a randomized, parallel-group, placebo-controlled, double-blind study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06159725
Sponsor's protocol ID
CMTX101-P1-CT002
Status last verified
Oct 2026
First submitted
29 Nov 2023
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CMTX-101 in people with Persistent Infection and Cystic Fibrosis, run by Clarametyx Biosciences, Inc. at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and % of participants experiencing adverse events following a single IV infusion of CMTX-101 (time frame: Day 1 to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06159725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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