# QUILT 3.032

Source: https://onco.cc/trials/quilt-3-032/  
OnCo record `quilt-3-032` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An IL-15 booster given with BCG produced complete responses in about 70% of patients with BCG-unresponsive carcinoma in situ and kept most bladders intact for years.

## Summary

QUILT 3.032, trial NCT03022825 sponsored by ImmunityBio and reported in 2022, showed that the IL-15 superagonist nogapendekin alfa inbakicept, or N-803, given with BCG produced complete responses in about seventy percent of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ and kept most bladders intact for years. In the single-arm CIS cohort of 77 patients the complete response rate was 71 percent with a median duration around two years, and the company's five-year update reported bladder preservation in more than eighty percent of responders at three years, leading to FDA approval on 22 April 2024 after a 2023 complete response letter over manufacturing. Without a randomised comparison, how it ranks against cretostimogene and nadofaragene is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03022825
- Phase: 2/3
- Setting: BCG-unresponsive NMIBC with CIS: nogapendekin alfa inbakicept (N-803) + BCG, single arm
- Sponsor: ImmunityBio
- Result: CR 71%.
- Outcomes: Complete response rate (CIS): N-803 + BCG 71%
- Replication: Single-arm; QUILT 2.005 (BCG-naive) and BCG-unresponsive papillary cohorts extend the evidence.

## Sources

- ClinicalTrials.gov NCT03022825: https://clinicaltrials.gov/study/NCT03022825

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/)
- drugs: [Intravesical BCG](https://onco.cc/drugs/bcg-intravesical/), [Nogapendekin alfa inbakicept](https://onco.cc/drugs/nogapendekin-alfa/)
- companies: [ImmunityBio](https://onco.cc/companies/immunitybio/)
- terms: [BCG-unresponsive](https://onco.cc/terms/bcg-unresponsive/)

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