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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

lyophilized inactivated group A Streptococcus TARA-002. A lyophilized formulation containing cultures of the low-virulent Su strain of group A Streptococcus pyogenes, treated and killed with penicillin G, with potential immunostimulating and antineoplastic activities. Upon intravesical administration, lyophilized inactivated group A Streptococcus TARA-002 may, as an immunostimulant, activate both the innate and adaptive immune system. This enhances neutrophils, monocytes and lymphocyte tumor infiltration and increases the production of key immune mediators, including interleukins IL-6, IL-8, IL-12, interferon (IFN)-gamma and tumor necrosis factor (TNF)-alpha, and vascular endothelial growth factor (VEGF), thereby inducing antitumor immune responses. TARA-002 is based on the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432. NCI Drug Dictionary

Treatments listed in the registry

• TARA-002 (Biological): 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.

Na · Single Group · masking: None

Main goals

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

Other goals

• Cohort A: Incidence of high-grade Complete Response at any time by subgroup (BCG naive and BCG exposed > 24 months) according to central pathology after treatment with TARA-002
• Cohort A and B: Duration of high-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
• Cohort A and B: High-grade Complete Response rate at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
• Cohort A and B: Duration of Complete Response (all recurrent bladder cancer, including low grade Ta) after treatment with TARA-002
• Cohort A and B: Complete Response rate (all recurrent bladder cancer, including low grade Ta) at Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60 after treatment with TARA-002
• Cohort A and B: Progression free survival after treatment with TARA-002
• Cohort A and B: Disease-specific progression free survival after treatment with TARA-002
• Cohort A and B: Overall survival after treatment with TARA-002
• Cohort A and B: Disease specific survival after treatment with TARA-002
• Cohort A and B: Time to cystectomy after treatment with TARA-002
• Cohort A and B: Time to recurrence delayed cystectomy after treatment with TARA-002
• Cohort A and B: Time to progression after treatment with TARA-002
• Cohort A and B: Time to disease worsening after treatment with TARA-002
• Cohort A and B: Incidence and severity of AEs, TEAEs, SAEs and TESAEs after treatment with TARA-002
• Cohort A and B: Change from baseline in urine pharmacodynamic biomarker levels (including IL-6, IL-8, IFN-γ, and TNF-α) after treatment with TARA-002
• Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-NMIBC24
• Cohort A and B: Quality of Life based on the EORTC questionnaire QLQ-C30

Planned enrollment: 131 (estimated).

• Urology Centers of Alabama, Homewood, Alabama
• Mayo Clinic, Phoenix, Arizona
• East Valley Urology Center of Arizona, Queen Creek, Arizona
• Arkansas Urology, Little Rock, Arkansas
• Michael Oefelein Clinical Trials, Bakersfield, California
• University of California Irvine Medical Center, Orange, California
• Genesis Research LLC, Torrance, California
• Colorado University - Anshutz, Aurora, Colorado
• AdventHealth Medical Group Urology of Denver, Denver, Colorado
• Advanced Urology, Lakewood, Colorado
• Urology Associates of Denver, Lone Tree, Colorado
• Mayo Clinic, Jacksonville, Florida
• Comprehensive Urologic Care, Lake Barrington, Illinois
• Southern Urology, Lafayette, Louisiana
• Brigham and Women's Hospital, Boston, Massachusetts
• Greater Boston Urology, LLC, Plymouth, Massachusetts
• Minnesota Urology, Woodbury, Bloomington, Minnesota
• Mayo Clinic, Rochester, Minnesota
• Renown Regional Medical Center, St Louis, Missouri
• Specialty Clinic Research of St. Louis, St Louis, Missouri
• Laura & Isaac Perlmutter Cancer Center - NYU Langone Health, New York, New York
• University of Rochester, Department of Urology, Rochester, New York
• Associated Medical Professionals of NY, PLLC, Syracuse, New York
• Montefiore Medical Center, The Bronx, New York
• Cleveland Clinic Main Campus, Cleveland, Cleveland, Ohio
• University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
• Carolina Urologic Research Center, Myrtle Beach, South Carolina
• Conrad Person Clinic, Memphis, Tennessee
• Urology Associates PC, Nashville, Tennessee
• Urology Partners of North Texas, Arlington, Texas
• Urology Austin, LLC, Austin, Texas
• Houston Metro Urology, Houston, Texas
• Houston Methodist Hospital, Houston, Texas
• UT Health San Antonio, San Antonio, Texas
• Virginia Urology, Richmond, Virginia
• Spokane Urology, Spokane, Washington

31 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05951179
• NCI Drug Dictionary: C185283

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 23, 2026. Public record; not medical advice.