eligibility_summary
Eligibility: Adults ≥18 with confirmed CF, stable modulator ≥3 mo, induced sputum with P. aeruginosa ≥10^4 CFU/g, FEV1 ≥50% (Part 1) or ≥35% (Part 2), on inhaled tobramycin/aztreonam with ≥1 cycle in past 8 wks, able to consent/complete visits, contraception per protocol. Exclusions: BMI <14, HIV/HBV/HCV RNA+, recent exacerbation, new antibiotics, or smoking/vaping, continuous O2, transplant, high LFTs, hemoptysis, M. abscessus/Burkholderia, pregnancy/breastfeeding, eGFR <60, other safety issues, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06159725 (Phase 1b/2a) in adults with CF chronically infected with Pseudomonas aeruginosa. Interventions: CMTX-101 (humanized monoclonal antibody, single IV dose 5/15/30 mg/kg) vs placebo, given adjunctive to standard inhaled antibiotics (tobramycin or aztreonam). Mechanism/type: biologic (mAb) designed to disrupt bacterial biofilms, by binding biofilm structural components in the extracellular polymeric matrix, it collapses P. aeruginosa biofilms, shifting bacteria toward a planktonic state to enhance antibiotic susceptibility and host clearance. Targets (cells/pathways): P. aeruginosa biofilm communities in CF airways, extracellular biofilm matrix/eDNA scaffolding pathways, indirectly supports innate immune phagocytic clearance and antibiotic bactericidal activity. Primary study focus: safety, PK, and immunogenicity (ADA/NAbs).