Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05871970 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Lymphatic Malformation, sponsored by Protara Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 10
- Study locations
NCT05871970: Recruiting Phase 2 study of Lymphatic Malformation, sponsored by Protara Therapeutics.
NCT05871970 is a Phase 2 study of Lymphatic Malformation that is actively recruiting participants, run by Protara Therapeutics. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05871970, a Phase 2 study of Lymphatic Malformation, is actively recruiting participants, sponsored by Protara Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 10
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL TARA-002
Study Locations (10)
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital/UAMS - Little Rock
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Medical Center: Children's Research Institute - Washington D.C.
Florida
- Nemours Children's Clinic - Jacksonville - Jacksonville
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- Children's Hospital of Philadelphia: Comprehensive Vascular Anomalies Program - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT05871970 shows while recruiting
NCT05871970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Lymphatic Malformation appearing as the primary indexed condition, and to 1 intervention - of which TARA-002 is the first listed.
NCT05871970 lists 10 locations in 10 states (Alabama, Arkansas, Colorado).
Frequently Asked Questions
What is clinical trial NCT05871970 about?
NCT05871970 is a clinical study titled "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". 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...
What is the current status of trial NCT05871970?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2023-10-18. Estimated completion is 2026-05.
What conditions does trial NCT05871970 study?
This clinical trial studies the following conditions: Lymphatic Malformation.
What interventions are being tested in trial NCT05871970?
The interventions under investigation include: TARA-002 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05871970?
This trial is sponsored by Protara Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05871970 being conducted?
This trial has 10 study locations across Alabama, Arkansas, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphatic Malformation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05871970's enrollment target sits among peer trials
38 1467th of 2000 higher than 518 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI