Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants 6 Months to Less Than 18 Years of Age
Start Date
10/18/2023
Completion Date
5/1/2027
Summary
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart.
Eligibility Criteria
Age Range: No minimum to 18 years
Interventions
TARA-002
Conditions
Locations
Children's Hospital of Alabama
Birmingham, Alabama 35294
United States
Arkansas Children's Hospital/UAMS
Little Rock, Arkansas 72202
United States
Children's Hospital of Colorado
Aurora, Colorado 88045
United States
Children's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia 20010
United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida 32207
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program
Philadelphia, Pennsylvania 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Children's Hospital of the King's Daughters
Norfolk, Virginia 23507
United States