BCG + nogapendekin alfa inbakicept

**BCG + nogapendekin alfa inbakicept** (also known by the clinical trial program name **QUILT-2.005**) is an investigational combination immunotherapy being developed by **ImmunityBio** (with originator **Altor BioScience**) for the treatment of BCG-naïve non-muscle-invasive bladder cancer (NMIBC). The combination consists of Bacillus Calmette-Guérin (BCG), a live attenuated bacterial vaccine that acts as a non-specific immunostimulant via Toll-like receptors (TLR2 and TLR4), and nogapendekin alfa inbakicept (Anktiva), a first-in-class interleukin-15 (IL-15) receptor superagonist. Nogapendekin alfa inbakicept is a fusion protein complex of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha-Fc fusion protein, which mimics the natural process of trans-presentation to activate and expand natural killer (NK) cells and CD8+ T cells without stimulating immunosuppressive regulatory T cells (Tregs). Administered intravesically, this combination synergistically enhances local antitumor immune responses. While already FDA-approved for BCG-unresponsive NMIBC, the combination is currently in Phase 2b development (under the QUILT-2.005 trial) for earlier-stage, BCG-naïve NMIBC, with a supplemental Biologics License Application (sBLA) planned for late 2026.

Other names

ALT-803 + BCGAnktiva + BCGN-803 + BCGVesAnktiva + BCGnogapendekin alfa inbakicept-pmln + BCGnogapendekin alfa-inbakicept + BCG