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.
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.
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
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Children's Hospital of Alabama, Birmingham, Alabama, United States, 35294
Arkansas Children's Hospital/UAMS, Little Rock, Arkansas, United States, 72202
Children's Hospital of Colorado, Aurora, Colorado, United States, 88045
Children's National Medical Center: Children's Research Institute, Washington, District of Columbia, United States, 20010
Nemours Children's Clinic - Jacksonville, Jacksonville, Florida, United States, 32207
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229
Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program, Philadelphia, Pennsylvania, United States, 19104
Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232
Children's Hospital of the King's Daughters, Norfolk, Virginia, United States, 23507
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.
For general information about clinical research, read Learn About Studies.
6 Months to 18 Years
ALL
No
Protara Therapeutics,
Chief Scientific Operations Officer, STUDY_DIRECTOR, Protara Therapeutics
2026-05