RECRUITING

An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705

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 objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.

Official Title

A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705

Quick Facts

Study Start:2022-03-08
Study Completion:2034-04-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05295433

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:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (COVID-19) vaccination during Study mRNA-3705-P101 Part 1.
  2. * Completed the End of treatment (EOT) Visit (or End of Study Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension study.
  1. * Not expected to receive clinical benefit from continued mRNA-3705 administration, in the opinion of the Investigator.
  2. * Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
  3. * History of liver and/or kidney transplant.

Contacts and Locations

Study Contact

Moderna WeCare Team
CONTACT
1-866-663-3762
WeCareClinicalTrials@modernatx.com

Study Locations (Sites)

UCLA Medical Center
Los Angeles, California, 90095
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Altman Clinical and Translational Research Institution
San Diego, California, 92037
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

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 Date2022-03-08
Study Completion Date2034-04-02

Study Record Updates

Study Start Date2022-03-08
Study Completion Date2034-04-02

Terms related to this study

Keywords Provided by Researchers

  • Isolated Methylmalonic acidemia
  • Isolated methylmalonic aciduria
  • Elevated methylmalonic acid (MMA)
  • Metabolism, Inborn Errors
  • Genetic Diseases
  • Moderna
  • mRNA
  • mRNA-3705

Additional Relevant MeSH Terms

  • Methylmalonic Acidemia