Recruiting
Phase 2

TARA-002

Sponsor:

Protara Therapeutics

Code:

NCT05871970

Conditions

Lymphatic Malformation

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

TARA-002

Study Details

Brief summary:

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.

Conditions

Lymphatic Malformation

Study ID

NCT05871970

Start date

Oct 18, 2023

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TARA-002

TARA-002 is a lyophilized biological preparation for injection containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.

Interventions

TARA-002

All participants will receive up to 4 intracystic injections spaced approximately 6 weeks apart.

Primary outcome measure

  • Proportion of participants with clinical success after one treatment cycle of TARA-002 [ Time Frame: 8 weeks after the last injection ]

Central Contacts and Locations

Central contacts

Chief R&D Officer

16468440337clinicaltrials@protaratx.com

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

TAYLOR BRINKLEY

tebrinkley@uabmc.edu

Arkansas Children's Hospital/UAMS

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

LEKIVIA COBB

cobblc@archildrens.org

Children's Hospital of Colorado

Recruiting

Aurora, Colorado, United States, 88045

Contacts

MATTHEW MCCLUNG

matthew.mcclung@childrenscolorado.org

Children's National Medical Center: Children's Research Institute

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

HENGAMEH BEHZADPOUR

hbehzadpou@childrensnational.org

Nemours Children's Clinic - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

ROSITA ALMIRA

rosita.almira@nemours.org

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

ARMAND HARB

armand.harb@mountsinai.org

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

LORI RUSSELL

watsonlo@ohsu.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

KALPNABEN PATEL

kalpnaben.patel@vumc.org

Children's Hospital of the King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

LAURA STONE

stonelj@odu.edu

More Information

Sponsor

Protara Therapeutics

Last update posted

Aug 24, 2026

Last verified

Apr, 2026

Keywords

  • Macrocystic lymphatic malformations
  • Mixed-cystic lymphatic malformations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Protara Therapeutics on 2026-08-24.