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QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

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Trial Profile

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 09 May 2025

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At a glance

  • Drugs BCG (Primary) ; Nogapendekin alfa inbakicept (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms QUILT-3.032
  • Sponsors ImmunityBio

Most Recent Events

  • 05 May 2025 According to an ImmunityBio media release, Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease.
  • 28 Apr 2025 According to an ImmunityBio media release, Based on findings from the QUILT-3.032 study, ImmunityBio recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for use of ANKTIVA plus BCG in BCG-unresponsive NMIBC for the indication of papillary disease.
  • 28 Apr 2025 According to an ImmunityBio media release, data from this study were published in oral presentation at the American Urological Association Annual Meeting (AUA 2025).

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