A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Spirovant Sciences, Inc.
Study ID
NCT06526923
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SP-101 and doxorubicin Cohort 1 — COMBINATION_PRODUCT
    Single inhaled dose of SP-101 and doxorubicin Dose 1
  • SP-101 and doxorubicin Cohort 2 — COMBINATION_PRODUCT
    Single inhaled dose of SP-101 and doxorubicin Dose 2

Study Details

This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.

Key Dates

Start date
Sep 16, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Single inhalational administration of SP-101 and doxorubicin Dose 1
  • Experimental: Cohort 2
    Single inhalational administration of SP-101 and doxorubicin Dose 2
  • Experimental: Dose Expansion
    Single inhalational administration of SP-101 and doxorubicin Selected Dose

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: 52 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Taryn McNickle
[email protected]
Joel Mermis (PRINCIPAL_INVESTIGATOR)
Boston Children's Hospital, Brigham & Women's HospitalBostonMassachusetts02115
Monica Ulles
[email protected]
Ahmet Uluer (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Barbara Djan
[email protected]
Claire Keating (PRINCIPAL_INVESTIGATOR)
Hospital at University of PennsylvaniaPhiladelphiaPennsylvania19104
Melissa Molter
[email protected]
Daniel Dorgan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KSBoston Children's Hospital, Brigham & Women's Hospital· Boston, MAColumbia University· New York, NYHospital at University of Pennsylvania· Philadelphia, PA

Related Studies