Tara-002 in Lymphatic Malformations

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This study is for people with growing abnormal lymph vessels called lymphatic malformations (LMs). This study has 3 parts and involves taking a study drug called TARA-002. The purpose of this study is to find out if the study drug is safe and effective (can help) people with LMs. Participants receive the study drug by injection and will complete other research assessments throughout the study. 

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at CVAPresearch [at] chop.edu or 267-426-0743.

Eligibility & Criteria

IRB #:
23-021092
Official Title:
A Phase 2a/b Single Arm Open Label Study to Evaluate the Safety and Efficacy of Intracystic Injection of TARA-002 in Participants Between 6 Months to Less than 18 Years of Age for the Treatment of Macrocystic and Mixed Cystic Lymphatic Malformations (STARBORN-1)
Study Phase:
Phase II
Eligible Age Range:
6 Months - 17 Years
Gender:
All
Study Categories:

Visit Criteria

This study will enroll patients who are at least 6 months of age and less than 18 years of age. Study participation lasts up to 54 weeks and requires 8 research clinic visits. This study has 3 parts: a Screening Period (about 4 weeks), a Treatment Period (about 18 weeks), and a Follow-up Period (about 32 weeks). Participants take the study drug injection up to 4 times about 6 weeks apart during the study visits. In addition to receiving study drug, visits include the following assessments: blood draws, electrocardiograms (ECGs), CT scans (x-rays), ultrasounds, photographs of lesions, completion of questionnaires, interviews, and diaries. Some study imaging procedures may require use of contrast and/or sedation (anesthesia). Some participants may have a penicillin allergy test and COVID-19 test.

Reimbursement for travel may be provided.

LEADERS

Sally Cohen-Cutler, MD, MS
Principal Investigator

Anne Marie Cahill, MBBch, BAO
Principal Investigator