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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: 08 Jun 2026

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At a glance

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

Most Recent Events

  • 19 May 2026 According to an ImmunityBio media release, the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA assigned a PDUFA target action date of January 6, 2027.
  • 05 May 2026 According to an ImmunityBio media release, data from this study will be presented at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18.
  • 09 Mar 2026 According to an ImmunityBio media release, he U.S. Food and Drug Administration (FDA) has acknowledged receipt of its supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

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