TARA-002 Injection for Lymphatic Malformations
(STARBORN-1 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to contact the trial sponsor for more details.
What data supports the effectiveness of the treatment TARA-002 for lymphatic malformations?
Research Team
Chief Scientific Operations Officer
Principal Investigator
Protara Therapeutics
Eligibility Criteria
This trial is for kids and teens from 6 months to under 18 years with large or mixed fluid-filled lumps in the head, neck, or chest area. They can join if they've had treatments before but not within the last six months. Kids allergic to penicillin, with blood vessel tumors, mostly small cysts, or eye socket involvement can't participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 2a Safety Lead-in
Safety lead-in, age de-escalation study to establish the safety of TARA-002 in older participants before proceeding to younger cohorts
Phase 2b Expansion
Expansion study where participants receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TARA-002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Protara Therapeutics
Lead Sponsor