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Evaluating the safety of CMTX-101 for cystic fibrosis patients

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

Phase1; Phase2 Interventional Clarametyx Biosciences, Inc. · NCT06159725

This study is testing a new treatment called CMTX-101 to see if it is safe for adults with cystic fibrosis who have had a specific lung infection.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment41 (estimated)
Ages18 Years and up
SexAll
SponsorClarametyx Biosciences, Inc. Industry-sponsored
Locations19 sites (Birmingham, Alabama and 18 other locations)
Trial IDNCT06159725 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and tolerability of CMTX-101, a monoclonal antibody designed to disrupt bacterial biofilms, in individuals with cystic fibrosis. Participants will receive either CMTX-101 or a placebo through intravenous infusion. The study aims to determine the safety of single doses, the pharmacokinetic profile of the drug, and the potential for the development of anti-drug antibodies. The trial includes adults with confirmed cystic fibrosis and a history of Pseudomonas aeruginosa infection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of cystic fibrosis and a history of Pseudomonas aeruginosa infection.

Not a fit: Patients who are not currently receiving inhaled antibiotic therapy or those with FEV1 below the required thresholds may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance the effectiveness of standard antibiotics for cystic fibrosis patients by targeting persistent infections.

How similar studies have performed: Other studies have explored similar approaches to treating cystic fibrosis, but the specific use of CMTX-101 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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).

   • 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).
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.

    • 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.
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.

Exclusion Criteria:

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.

Where this trial is running

Birmingham, Alabama and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Persistent InfectionCystic FibrosisPseudamonas auriginosa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.