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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: 25 Sep 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 Aug 2025 According to an ImmunityBio media release, the company conducted a Type A meeting with the FDA in June 2025 and provided new data in the papillary-only NMIBC new data based on 26 of the 100 subjects in Cohort A and 80 subjects in Cohort B (Papillary Alone). The company indicated it may Withdraw the prior sBLA and submit a new one with updated data Or amend the existing sBLA with a commitment to initiate an RCT comparing ANKTIVA + BCG vs chemotherapy in papillary-only NMIBC.
  • 25 Jul 2025 According to an ImmunityBio media release, the Company indicated that it would withdraw the prior sBLA filing. But, the company is re-evaluating this approach in consultation with its regulatory counsel and may seek to amend the initial filing with the new data rather than withdrawing it, with a commitment to initiate a randomized controlled trial of chemotherapy free ANKTIVA + BCG versus chemotherapy in the papillary alone indication.
  • 07 Jul 2025 According to an ImmunityBio media release, the company announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA in combination with Bacillus Calmette-Guerin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent.

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