RECRUITING

A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objectives of this study are to evaluate the safety of a single intrathecal (IT) dose of TSHA-102 in females with typical Rett syndrome, to select the TSHA-102 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the efficacy and safety of TSHA-102 at the selected dose.

Official Title

An Open-label Phase 1/2/3 Study Consisting of a Phase 1/2 Safety and Dose-escalation and Phase 3 Dose-expansion Study to Evaluate Safety and Efficacy of a Single Intrathecal Administration of TSHA-102, an AAV9-Delivered Gene Therapy in Females With Rett Syndrome

Quick Facts

Study Start:2023-03-06
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05606614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Females between the ages of 12 and \<22 in Part A (closed) and females between the ages of 6 and \<22 in Part B (pivotal cohort).
  2. * Participant has a clinical diagnosis of classic/typical Rett syndrome with a documented pathogenic mutation of the methyl-CpG-binding protein 2 (MECP2) gene that results in loss of gene function.
  3. * Participants must be willing to receive blood or blood products for the treatment of an AE if medically needed.
  4. * Participants and parent/caregiver must agree to reside within easy access to the study site prior to the baseline visit and at least 3 months after TSHA-102 treatment
  1. * Participant has another neurodevelopmental disorder independent of the MECP2 loss-of-function mutation, or any other genetic syndrome with a progressive course.
  2. * Participant has a history of brain injury that causes neurological problems or had grossly abnormal psychomotor development in the first 6 months of life.
  3. * Participant has a diagnosis of atypical Rett syndrome or a MECP2 gene mutation that does not cause Rett syndrome.
  4. * Participant requires invasive ventilatory support.

Contacts and Locations

Study Contact

Taysha Gene Therapies Medical Information
CONTACT
833-489-8742
medinfo@tayshagtx.com

Principal Investigator

Medical Monitor, M.D.
STUDY_DIRECTOR
Taysha Gene Therapies

Study Locations (Sites)

UC San Diego
La Jolla, California, 92093
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Washington University, St. Louis
St Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Taysha Gene Therapies, Inc.

  • Medical Monitor, M.D., STUDY_DIRECTOR, Taysha Gene Therapies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-06
Study Completion Date2031-06

Study Record Updates

Study Start Date2023-03-06
Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

  • Rett Syndrome
  • Neurodevelopmental disorder
  • Rett
  • MECP2
  • AAV9
  • Typical Rett Syndrome
  • Classic Rett Syndrome
  • RTT
  • Rett Disorder
  • Retts
  • MECP2-Related Disorder
  • Gene Therapy
  • Intrathecal Administration
  • Genetic Diseases, X-Linked
  • Nervous System Diseases
  • Developmental Regression
  • TSHA-102
  • miRARE
  • Self-complementary Vector
  • Neurologic Manifestations
  • Intellectual Disability
  • Pathologic Process
  • X-Linked Intellectual Disability
  • Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Additional Relevant MeSH Terms

  • Rett Syndrome