A Phase 2 interventional study of TARA-002 in Lymphatic Malformation, sponsored by Protara Therapeutics. Recruiting at 11 sites in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Protara Therapeutics · Phase 2, Interventional, and Treatment
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.
42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.
This study's planned enrollment of 38 is below the median of 46 across 28 interventional studies indexed under Lymphatic Abnormalities.
Browse Lymphatic Abnormalities studies →Protara Therapeutics is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
For more information on eligibility criteria, please contact the sponsor.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TARA-002 is a lyophilized biological preparation for injection containing cells of Streptococcus pyogenes (Group A, type 3) Su strain treated with benzylpenicillin.
Biological: TARA-002
Drug pages: Picibanil · Lyophilized Inactivated Group A Streptococcus TARA-002
All participants will receive up to 4 intracystic injections spaced approximately 6 weeks apart.
Proportion of participants with clinical success after one treatment cycle of TARA-002
Time frame: 8 weeks after the last injection
Safety: Percentage of participants with solicited local site and systemic reactions
Time frame: 14 days (2 weeks) after each injection
Safety: Percentage of participants with unsolicited adverse events (AEs)
Time frame: Through study completion (approximately 32 weeks after last injection)
Safety: Percentage of participants with SAEs, AEs of special interest, AEs leading to premature discontinuation of study intervention, AEs leading to withdrawal from study, AEs with an outcome of death, and MAAEs
Time frame: Through study completion (approximately 32 weeks after last injection)
Durable Response: Proportion of participants with clinical success after one treatment cycle of TARA-002 assessed at 8 weeks after the last injection and maintained clinical success at 32 weeks after the last injection
Time frame: 32 weeks after the last injection
Clinical Success by LM Type: Proportion of participants with macrocystic LM or mixed cystic LM with clinical success after one treatment cycle of TARA-002
Time frame: 8 weeks after the last injection
Investigator Assessment: Proportion of participants who demonstrate clinical improvement, as assessed by the Investigator, after one treatment cycle of TARA-002 compared to baseline
Time frame: 8 weeks after last injection and 32 weeks after last injection
Quality of Life: Change in Quality-of-Life assessment based on Pediatric Quality of Life Inventory (PedsQL) and Visual Analog Scale (VAS) for Pain after one treatment cycle of TARA-002
Time frame: 8 weeks after last injection and 32 weeks after last injection
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Plan to share: No
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Studies of the drugs tested here: Picibanil · Lyophilized Inactivated Group A Streptococcus TARA-002
Protara Therapeutics