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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: 26 Feb 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 Feb 2026 According to an ImmunityBio media release, the European Commission has granted conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.
  • 20 Jan 2026 Results presented in the ImmunityBio Media Release
  • 20 Jan 2026 According to an ImmunityBio media release, Following discussions with the U.S. Food and Drug Administration (FDA), the Agency recommended that the Company provide additional information for its consideration to support evaluation of a potential resubmission of the sBLA for BCG-unresponsive papillary NMIBC

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