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ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer

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Trial Profile

ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs Recombinant Mycobacterium Bacillus Calmette-Guerin therapeutic ImmunityBio (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Expanded access; Therapeutic Use
  • Sponsors ImmunityBio

    • Most Recent Events

    • 01 Apr 2025 Status changed from suspended to recruiting.
    • 03 Mar 2025 According to an ImmunityBio media release, the first patient dosed with rBCG in the United States is anticipated in March 2025. Company anticipates that over 45,000 vials of rBCG will be available for the United States in 2025 to address the overall BCG shortage.
    • 03 Mar 2025 According to an ImmunityBio media release, FDA authorization of expanded access of an alternative source of BCG in February 2025 is expected to address the issue of BCG shortage with over 45,000 doses available, over 60 sites are now being activated to receive recombinant BCG (rBCG) under the Expanded Access Program.

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