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Safety and Efficacy Study of TARA-002 for Lymphatic Malformations

This study is testing a treatment called TARA-002 for children and teens aged 6 months to less than 18 years who have lymphatic malformations (LMs). LMs are abnormal growths of the lymphatic system, which is part of the body's immune system. The study aims to see how safe TARA-002 is and how well it works to treat macrocystic LMs or mixed cystic LMs (where at least 50% is macrocystic). All participants will receive up to four injections of TARA-002 directly into the LM, about 6 weeks apart. The main goal is to see how many participants have a successful outcome after one treatment cycle, measured 8 weeks after their last injection. This study is currently unclear in its recruitment status.

Study design
This is a Phase 2a/b, single-arm, open-label study, meaning all participants receive the study treatment and everyone knows what treatment is being given. It plans to enroll 38 participants.
What's involved
Participants will receive up to 4 intracystic injections of TARA-002, spaced approximately 6 weeks apart.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured 8 weeks after the last injection.

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NCT05871970

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

Recruiting
PHASE2Ages 6–18InterventionalTreatment
Protara Therapeutics
~38 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:TARA-002

At a glance

Recruiting sites
9 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with clinical success after one treatment cycle of TARA-002
Measured over 8 weeks after the last injection

Conditions

Lymphatic Malformation

Explore related trials

Lymphatic malformation

Where it's being run

11 sites across 11 states
Alabama1
Arkansas1
Colorado1
District of Columbia1
Florida1
New York1
Ohio1
Oregon1

Study leadership

  • Chief R&D Officer · STUDY_DIRECTOR · Protara Therapeutics

Who to contact

Chief R&D Officer
[email protected]
16468440337
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Eligibility criteria

Inclusion

Male or female participants 6 months to less than 18 years of age at the time of informed consent/assent form was signed
Participants whose parent/LAR(s) have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them
Participants with macrocystic LM or mixed cystic LM (≥ 50% macrocystic disease measured by volume) of the Head/Neck/Mediastinum according to the ISSVA 2018 criteria (ISSVA 2018) measured via LM imaging at Screening to confirm, upon central review, the diagnosis of macrocystic or mixed cystic LM
Participants who may have had surgical or sclerotherapy treatment for their LM, but not within six months of the consent/assent form being signed

Exclusion

Penicillin allergy
Vascular tumors or combined vascular malformations
Microcystic LM or mixed cystic LM with predominant microcystic features
LMs of the orbit (orbital LM) as target cyst

What this trial measures

  • Proportion of participants with clinical success after one treatment cycle of TARA-0028 weeks after the last injection