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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: 05 Aug 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

  • 29 Jul 2026 According to an ImmunityBio media release, The Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) granted Marketing Authorization to ANKTIVA 0.4 mg/0.4 mL (solution for intravesical instillation) in combination with Bacillus Calmette-Guerin (BCG) for BCG-unresponsive NMIBC. The approval is supported by results from this study.
  • 02 Jun 2026 Results presented at the 62nd Annual Meeting of the American Society of Clinical Oncology
  • 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.

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