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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

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: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 07 Feb 2024

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At a glance

  • Drugs BCG (Primary) ; Inbakicept (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms QUILT-3.032
  • Sponsors ImmunityBio
  • Most Recent Events

    • 05 Feb 2024 According to an ImmunityBio media release, data from this study were published by the peer-reviewed journal Urology Practice.
    • 05 Feb 2024 Results (May 16, 2022 data cutoff) published in an ImmunityBio Media Release.
    • 26 Oct 2023 According to an ImmunityBio media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted for review resubmission of its Biologics License Application (BLA) for N-803 for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and considered it as a complete response to the FDA's May 9, 2023 complete response letter. The FDA has set a user fee goal date (PDUFA date) of April 23, 2024.
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