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NCT05871970 | RECRUITING | Lymphatic Malformation

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
Sponsor:

DRAWER CROSS

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.

Condition or disease

Lymphatic Malformation

Intervention/treatment

TARA-002

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 38 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2a/b Single Arm Open Label Study to Evaluate the Safety and Efficacy of Intracystic Administration 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
Actual Study Start Date : 2023-10-18
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Months to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT05871970

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

Children's Hospital of Alabama

Birmingham, Albama, United States, 35294

RECRUITING

United States, Arkansa

Arkansas Children's Hospital / Uams

Little Rock, Arkansa, United States, 72202

RECRUITING

United States, Colorado

Children's Hospital of Colorado

Aurora, Colorado, United States, 88045

RECRUITING

United States, District of Columbia

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

Washington, District of Columbia, United States, 20010

RECRUITING

United States, Florida

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, United States, 32207

RECRUITING

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Virginia

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States, 23507