CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)

NCT04684641 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 200002916020-004179
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa. In addition, study evaluates the safety profile of phage therapy in this patient population.

Conditions

Cystic Fibrosis

Keywords

Pseudomonas; bacteriophage; phage

Outcome Measures

Primary Outcomes (1)

• Change in Sputum Bacterial Culture

  Change in sputum bacterial culture titers of Pseudomonas as measured by colony forming units/mL at day 14

  Day 14

Secondary Outcomes (5)

• Change in Lung Function

  Screening, day 14, day 21, day 28, and day 56

• Difference in the Rate of Pulmonary Exacerbations

  Baseline, day 56

• Difference in the Rate of Hospitalization

  Baseline, day 56

• Difference in the Rate of Acute Antibiotic Use

  Baseline, day 56

• Patient's Quality of Life

  Baseline, day 56

Study Arms (2)

Phage therapy

EXPERIMENTAL

Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.

Drug: Standard Dose YPT-01

Placebo

ACTIVE COMPARATOR

Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.

Other: Placebo

Interventions

Standard Dose YPT-01 DRUG

Participants will be randomized to receive the standard dose of phage therapy YPT-01.

Also known as: Phage Therapy

Phage therapy

Placebo OTHER

Participants will be randomized to receive the placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Age ≥18;
• CF diagnosis based upon genetics, sweat chloride testing, or clinical manifestations;
• Able to provide repeated induced sputum samples;
• Able to use a nebulizer;
• PsA culture positive on one occasions within past 2 years and in sputum at screening visit;
• FEV1 \>40%;
• Clinically stable lung disease, defined as no decrease in FEV1 \>10% or pulmonary exacerbations in the 4 weeks prior to screening;
• If on CF modulator therapy (e.g., ivacaftor, ivacaftor/elexacaftor/tezacaftor), then subject remains on the same modulator therapy for at least 2 months prior to enrollment;
• For females of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use 2 methods of effective contraception during study participation and for an additional 6 weeks after the end of YPT-01 administration;
• Males of non-reproductive potential (e.g., documented congenital bilateral absence of vas deferens) or males of reproductive potential (e.g., non-vasectomized males or males vasectomized less than 120 days prior to study start) that agree to use condoms with spermicide while engaging in sexual activity or be sexually abstinent.

You may not qualify if:

• History of solid organ transplant (e.g., lung or liver);
• Severe neutropenia, as defined by absolute neutrophil count (ANC) of \< 500 per microliter;
• No YPT-01 phage identified that effectively targets sputum PsA;
• Treatment for pulmonary exacerbation within the prior 4 weeks;
• Change in pulmonary medications within the prior 4 weeks;
• Subjects who are pregnant, who intend to become pregnant, or who do not wish to use contraception;
• Subjects who are breastfeeding;
• Participation in another clinical research study concurrently or within the prior 2 months;
• Known allergy to soy, egg, yeast, or meat.
• Any genetic or acquired (including medication-induced) immunocompromised condition, beyond the level of immunocompromise typically associated with CF and its management.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Interventions

Phage Therapy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jonathan Koff
• Organization: Yale University

jon.koff@yale.edu

475-224-8167

Study Officials

• Jonathan Koff, MD

  Yale University

  STUDY DIRECTOR

• Benjamin Chan, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adult Cystic Fibrosis Program

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 24, 2020
• Study Start: March 29, 2021
• Primary Completion: May 26, 2023
• Study Completion: June 22, 2023
• Last Updated: November 18, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-10

Locations

US (1)