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Study of TARA-002 for High-Grade Non-Muscle Invasive Bladder Cancer

This study is testing a treatment called TARA-002 for adults with high-grade non-muscle invasive bladder cancer (NMIBC), which is cancer in the bladder lining that hasn't spread to deeper muscle. All participants will receive TARA-002 directly into the bladder once a week for six weeks. If needed, some participants might receive another six weekly doses. Researchers want to see how safe and effective TARA-002 is, specifically looking for a complete response (meaning the cancer is gone) between 3 and 60 months after treatment. You may be able to join if you are 18 or older, have this type of bladder cancer, and have active disease confirmed by a doctor.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving TARA-002. It plans to enroll 131 participants.
What's involved
You will receive TARA-002 directly into your bladder once a week for six weeks. Some participants may receive an additional six weekly doses.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for a complete response between 3 and 60 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05951179

Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Protara Therapeutics
~131 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:TARA-002

At a glance

Recruiting sites
67 of 78 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002
Measured over Month 3 to Month 60

Conditions

Non-muscle Invasive Bladder Cancer

Explore related trials

Bladder CarcinomaCarcinoma In Situ

NCT05951179

Where you'd take part

This study runs at 78 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Urology

    Lakewood, Coloradono site contact published

    Recruiting

  • AdventHealth Medical Group Urology of Denver

    Denver, Coloradono site contact published

    Recruiting

  • Arensia Kapitanivka - PPDS

    Kapitanivka, Ukraineno site contact published

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansasno site contact published

    Recruiting

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New Yorkno site contact published

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsno site contact published

    Recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolinano site contact published

    Recruiting

  • CEMAIC

    Córdoba, Argentinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Chief Scientific Operations Officer · STUDY_DIRECTOR · Protara Therapeutics

Who to contact

Chief Scientific Operations Officer
[email protected]
16468440337
Email the study team

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Eligibility criteria

Inclusion

Male or female participants 18 years of age or older at the time of signing informed consent
Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry
Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease
Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (± Ta/T1) who are BCG unresponsive.

Exclusion

Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
Central confirmed variant histology
Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment
Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)
Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history

What this trial measures

  • Cohort A and B: Incidence of high-grade Complete Response at any time according to central pathology after treatment with TARA-002Month 3 to Month 60