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

Conditions

• Lymphatic Malformation

Eligibility Criteria

Sex

ALL

Age

6 Months - 18 Years

Healthy Volunteers

Not accepted

Interventions

• TARA-002 — BIOLOGICAL
  All participants will receive up to 4 intracystic injections spaced approximately 6 weeks apart.

Study Details

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.

Key Dates

Start date

Oct 18, 2023

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

May 31, 2027

Study Design

Enrollment

38 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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

• Chief Scientific Operations Officer
  16468440337
  [email protected]

Locations (10)

Find similar trials in Birmingham, AL

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