Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

NCT07227285 — Phase 1 / Phase 2, Not yet recruiting, 16 participants, Cyllene Therapeutics
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Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy Expressing a Transgene Encoding the Light Chain of Botulinum Toxin F

RegistryNCT07227285
StatusNot yet recruiting
PhasePhase 1 / Phase 2
Study typeInterventional; na, single group, masking: none, other
Enrollment16 (Estimated)
SponsorCyllene Therapeutics (Industry)
ConditionsUrinary Bladder, Overactive, Spinal Cord Injury
InterventionsUrodynamics, EG110A, Patient-reported Outcome (Other, drug)
Datesstart 2026-04-01 (estimated), primary completion 2031-04-01 (estimated), completion 2031-04-01 (estimated), first posted 2025-11-12, last updated 2025-11-12
Locations4 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Urinary Bladder, Overactive All trials for Spinal Cord Injury All trials of Urodynamics All trials of EG110A

-Summary

The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.

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+Detailed description

The objective of this long-term follow-up study is to continue following participants who have received EG110A for safety, and to observe long-term efficacy via a disease-specific quality of life questionnaire, time to participant request for alternative treatment, and locally-evaluated urodynamics.

This study aims to identify any potential long-term risks and will capture any delayed adverse events (AEs) in participants following the last study visit of the preceding study. Additionally, it will allow the Sponsor to further understand the long-term effectiveness of EG110A in this patient population.

+Arms and interventions

ArmTypeInterventionsDescription
Patients who received EG110A in a clinical study, regardless of doseExperimentalOther: Urodynamics; Drug: EG110A; Other: Patient-reported Outcome
  • Urodynamics (Other): standardized local evaluation of urodynamic parameters
  • EG110A (Drug): Patients already treated with EG110A
  • Patient-reported Outcome (Other): assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

+Outcome measures

Primary outcomes

  • Incidence of treatment emergent serious adverse events (TESAEs) [5 years]: Any participant who has a reported treatment emergent serious adverse event (TESAE)
  • Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs) [5 years]: Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)

Secondary outcomes

  • Patient-reported outcome (PRO) questionnaire [5 years]: Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study
  • Duration of response to EG110A [5 years]: Time from initial treatment with EG110A to request an alternative treatment for NDO by the participant at any time during the long-term follow-up study

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

\- All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.

Exclusion Criteria:

* Participant plans to participate in another investigational gene therapy study
* Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator

+Locations (4)

FacilityCityCountryStatus
Rancho Los Amigos National Rehabilitation CenterDowney, CaliforniaUnited States
University of Michigan Rogel Cancer CenterAnn Arbor, MichiganUnited States
Sidney Kimmel Medical CollegePhiladelphia, PennsylvaniaUnited States
UTHealth Houston / TIRR Memorial HermannHouston, TexasUnited States

+Investigators