Treatment of lymphatic malformations in children using TARA-002

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a/b open-label study evaluates the safety and efficacy of TARA-002, administered via intracystic injection, for treating macrocystic and mixed cystic lymphatic malformations in children aged 6 months to less than 18 years. The study begins with a safety lead-in phase for older participants before expanding to younger cohorts. Participants will receive up to four injections spaced approximately six weeks apart, with safety being established at each age level before proceeding to the next. The study aims to confirm the effectiveness of TARA-002 in reducing lymphatic malformations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

For more information on eligibility criteria, please contact the sponsor.

Where it's running

• Children's Hospital of Alabama
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital/UAMS
  Little Rock, Arkansas, United States Recruiting
• Children's Hospital of Colorado
  Aurora, Colorado, United States Recruiting
• Children's National Medical Center: Children's Research Institute
  Washington D.C., District of Columbia, United States Recruiting
• Nemours Children's Clinic - Jacksonville
  Jacksonville, Florida, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Chief R&D Officer
• Email: clinicaltrials@protaratx.com
• Phone: 16468440337

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry and biobank for lymphatic malformations in Italy

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• Using sirolimus to treat cystic lymphatic malformations in children

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• Using Bleomycin for treating lymphatic malformations in children

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• Using indocyanine green imaging to treat cystic lymphatic malformation in children

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  Recruiting Nanjing Children's Hospital · Nanjing, Jiangsu · NCT06275022

• Targeted therapies for patients with vascular malformations

  This study is testing new targeted treatments for patients with slow-flow and fast-flow vascular malformations to see if they work better than the usual therapies.

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• Weekly treatment with sirolimus for venous and lymphatic malformations

  This study is testing if giving sirolimus once a week can help people with venous and lymphatic malformations feel better while causing fewer side effects than taking it every day.

  Recruiting Phase 2 Medical University of South Carolina · Charleston, South Carolina · NCT04861064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.