A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Public ClinicalTrials.gov record NCT02010203. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response & Clinical Activity of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1\*10\^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1\*10\^6 cells) or high dose (1\*10\^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1\*10\^7 cells) intradermal HS-410 monotherapy.
Study identification
- NCT ID
- NCT02010203
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 104 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2013 (Type not available)
- Primary completion
- Dec 2017 (Actual)
- Completion
- Apr 2018 (Actual)
- Last update posted
- Feb 17, 2020
2013 – 2018
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095 | — |
| Skyline Urology | Sherman Oaks | California | 91411 | — |
| Skyline Urology | Torrance | California | 90505 | — |
| Urology Center of Colorado | Denver | Colorado | 80211 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| First Urology | Jeffersonville | Indiana | 47130 | — |
| Horizon Oncology Research | Lafayette | Indiana | 47905 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| University of Massachusetts | Worcester | Massachusetts | 01655 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Montefiore Medical Center | The Bronx | New York | 10471 | — |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology of North Texas | Dallas | Texas | 75231 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02010203, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02010203 live on ClinicalTrials.gov.