CompletedPhase 1/2

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

United States43 participantsStarted 2024-06-24

Plain-language 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). 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 1 to Day 28

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

Timeframe: Day 1 to Day 28

Trial details

NCT IDNCT06159725

SponsorClarametyx Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-14

View on ClinicalTrials.gov More Persistent Infection trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. FEV1 ≥50% (Part1) or ≥35% (Part 2) of predicted normal value at screening.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria