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

Safety: Percentage of participants with solicited local site and systemic reactions

Time frame: 14 days (2 weeks) after each injection

Safety: Percentage of participants with unsolicited adverse events (AEs)

Time frame: Through study completion (approximately 32 weeks after last injection)

Safety: Percentage of participants with SAEs, AEs of special interest, AEs leading to premature discontinuation of study intervention, AEs leading to withdrawal from study, AEs with an outcome of death, and MAAEs

Time frame: Through study completion (approximately 32 weeks after last injection)

Durable Response: Proportion of participants with clinical success after one treatment cycle of TARA-002 assessed at 8 weeks after the last injection and maintained clinical success at 32 weeks after the last injection

Time frame: 32 weeks after the last injection

Clinical Success by LM Type: Proportion of participants with macrocystic LM or mixed cystic LM with clinical success after one treatment cycle of TARA-002

Time frame: 8 weeks after the last injection

Investigator Assessment: Proportion of participants who demonstrate clinical improvement, as assessed by the Investigator, after one treatment cycle of TARA-002 compared to baseline

Time frame: 8 weeks after last injection and 32 weeks after last injection

Quality of Life: Change in Quality-of-Life assessment based on Pediatric Quality of Life Inventory (PedsQL) and Visual Analog Scale (VAS) for Pain after one treatment cycle of TARA-002

Time frame: 8 weeks after last injection and 32 weeks after last injection