TARA-002 Injection for Lymphatic Malformations

(STARBORN-1 Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Protara Therapeutics

Disqualifiers: Penicillin allergy, Vascular tumors, Microcystic LM, others

No Placebo Group

Prior Safety Data

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?

The treatment TARA-002 is similar to the immunostimulant OK-432, which has shown excellent long-term outcomes for patients with lymphatic malformations. This suggests that TARA-002 might also be effective for this condition.

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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

I had surgery or sclerotherapy for my LM, but not in the last 6 months.

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

I am between 6 months and 18 years old.

Exclusion Criteria

My target cyst is in the eye socket area.

My condition involves blood vessel tumors or malformations.

My condition involves small cysts in my lymphatic system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Variable, based on cohort completion

Phase 2b Expansion

Expansion study where participants receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart

18-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

The study tests TARA-002 injections directly into these lumps. It's a two-part study: first ensuring it's safe for older kids (6-17 years) then younger ones (6 months-5 years). If safe, more kids will get up to four shots about six weeks apart in the second part of the study.

Group I: TARA-002 Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital of Colorado Aurora, CO

Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program Philadelphia, PA

Cincinnati Children's Hospital Medical Center Cincinnati, OH

Oregon Health & Science University Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Protara Therapeutics Lead Sponsor

References

1. China pubmed.ncbi.nlm.nih.gov

[Management for lymphatic malformation in infants: a single center experience]. [2018] To assess the therapeutic effect of management for lymphatic malformation (LM) in infants.

2. United States pubmed.ncbi.nlm.nih.gov

Risk Factors for Sequelae After Surgery for Lymphatic Malformations in Children. [2023] The first-line treatment of lymphatic malformations (LM) is pharmacological or interventional, however, surgery is still necessary in selected cases. Our aim was to identify factors associated with the occurrence of permanent postoperative complications.

3. Norway pubmed.ncbi.nlm.nih.gov

Patients with lymphatic malformations who receive the immunostimulant OK-432 experience excellent long-term outcomes. [2015] Sclerotherapy is the primary treatment for lymphatic malformations. The aim of this study was to evaluate the long-term outcome in patients with lymphatic malformations treated with the immunostimulant OK-432 as a sclerosant.

4. United States pubmed.ncbi.nlm.nih.gov

Pediatric admissions and procedures for lymphatic malformations in the United States: 1997 and 2000. [2007] To describe the incidence of discharges for lymphatic malformation (LM) and the various treatments rendered for this condition in a nationwide sampling of pediatric discharges from 1997 and 2000.

5. India pubmed.ncbi.nlm.nih.gov

Efficiency and clinical results of bleomycin injection in the treatment of lymphatic malformations. [2023] Lymphatic malformations (LMs) are rare congenital anomalies. The traditional treatment is surgical excision, but intralesional sclerosing agent injection is also preferred as the first-choice treatment because of postoperative frequent recurrences, poor cosmetic results, and high complication rate. We aimed to evaluate the efficacy of sclerosing agent injection used in the treatment of LMs in children.