{"entity":{"id":"quilt-3-032","kind":"trial","name":"QUILT 3.032","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03022825","url":"https://clinicaltrials.gov/study/NCT03022825"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["nogapendekin-alfa","bcg-intravesical"],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03022825","phase":"2/3","setting":"BCG-unresponsive NMIBC with CIS: nogapendekin alfa inbakicept (N-803) + BCG, single arm","sponsor":"ImmunityBio","result":"CR 71%.","started":"2017-06-02","startedType":"actual","yearReported":2022,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response rate (CIS)","primary":true,"unit":"%","arms":[{"name":"N-803 + BCG","n":77,"value":71}],"source":"https://doi.org/10.1056/EVIDoa2200167"}],"replication":"Single-arm; QUILT 2.005 (BCG-naive) and BCG-unresponsive papillary cohorts extend the evidence."},"route":"/trials/quilt-3-032/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"}],"drug":[{"id":"bcg-intravesical","kind":"drug","name":"Intravesical BCG","route":"/drugs/bcg-intravesical/"},{"id":"nogapendekin-alfa","kind":"drug","name":"Nogapendekin alfa inbakicept","route":"/drugs/nogapendekin-alfa/"}],"company":[{"id":"immunitybio","kind":"company","name":"ImmunityBio","route":"/companies/immunitybio/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"}]}}