Recruiting
Phase 2

TARA-002

Sponsor:

Protara Therapeutics

Code:

NCT05951179

Conditions

Non-muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TARA-002

Study Details

Brief summary:

TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).

The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).

This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.

Participants will be enrolled into one of 2 cohorts:

Cohort A:

  • Participants with CIS (± Ta/T1) who are BCG naive, or
  • Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis

Cohort B:

  • Participants who are BCG unresponsive

Conditions

Non-muscle Invasive Bladder Cancer

Study ID

NCT05951179

Start date

Sep 15, 2023

Status verified date

Jan, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Oct, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

For more information on eligibility criteria, please contact the Sponsor

Study Design

Enrollment

131 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TARA-002

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

Interventions

TARA-002

All participants will receive 6 weekly instillations of TARA-002 at the established RP2D (First Treatment Period). Participants who are eligible for reinduction after the First Treatment Period will receive 6 additional weekly doses of TARA-002 instillation as part of the Second Treatment Period. Participants confirmed to have a complete response after the First Treatment Period will receive 3 additional weekly doses of TARA-002 instillation as maintenance during the Second Treatment Period. All eligible participants will receive 3 weekly doses of TARA-002 instillation as part of the Third Treatment Period (maintenance) at Months 6, 9, 12, 15, 18 and 24. Following the Third Treatment Period, all participants will continue to the Follow up Period from Month 27 until Month 60.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chief Scientific Operations Officer

16468440337clinicaltrials@protaratx.com

Locations

Urology Centers of Alabama

Recruiting

Homewood, Alabama, United States, 35209

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

East Valley Urology Center of Arizona

Recruiting

Queen Creek, Arizona, United States, 85140

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

Michael Oefelein Clinical Trials

Recruiting

Bakersfield, California, United States, 93301

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92697

Genesis Research LLC

Recruiting

Torrance, California, United States, 90505

Colorado University - Anshutz

Recruiting

Aurora, Colorado, United States, 80045

AdventHealth Medical Group Urology of Denver

Recruiting

Denver, Colorado, United States, 80211

Advanced Urology

Recruiting

Lakewood, Colorado, United States, 80228

Urology Associates of Denver

Recruiting

Lone Tree, Colorado, United States, 80124

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Comprehensive Urologic Care

Recruiting

Lake Barrington, Illinois, United States, 60010

Southern Urology

Recruiting

Lafayette, Louisiana, United States, 70508

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Greater Boston Urology, LLC

Recruiting

Plymouth, Massachusetts, United States, 02360

Minnesota Urology, Woodbury

Recruiting

Bloomington, Minnesota, United States, 55425

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Renown Regional Medical Center

Recruiting

St Louis, Missouri, United States, 63110

Specialty Clinic Research of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Laura & Isaac Perlmutter Cancer Center - NYU Langone Health

Recruiting

New York, New York, United States, 10016

University of Rochester, Department of Urology

Recruiting

Rochester, New York, United States, 14642

Associated Medical Professionals of NY, PLLC

Recruiting

Syracuse, New York, United States, 13210

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Cleveland Clinic Main Campus, Cleveland

Recruiting

Cleveland, Ohio, United States, 44195

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Conrad Person Clinic

Recruiting

Memphis, Tennessee, United States, 38128

Urology Associates PC

Recruiting

Nashville, Tennessee, United States, 37209

Urology Partners of North Texas

Recruiting

Arlington, Texas, United States, 76017

Urology Austin, LLC

Recruiting

Austin, Texas, United States, 78745

Houston Metro Urology

Recruiting

Houston, Texas, United States, 77027

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Virginia Urology

Recruiting

Richmond, Virginia, United States, 23235

Spokane Urology

Recruiting

Spokane, Washington, United States, 99202

UHN Princess Margaret Cancer Centre Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

The Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3H 2R9

More Information

Sponsor

Protara Therapeutics

Last update posted

Aug 24, 2026

Last verified

Jan, 2026

Keywords

  • Non-muscle invasive bladder Cancer
  • bladder cancer
  • high grade Ta
  • high grade NMIBC
  • carcinoma in situ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Protara Therapeutics on 2026-08-24.