{"entity":{"id":"rocapuldencel-t","kind":"drug","name":"Rocapuldencel-T","aka":["AGS-003","AGS-003-LNG","AGS-003-BLD"],"tldr":"Rocapuldencel-T is an individualised autologous dendritic cell immunotherapy from Argos Therapeutics that reached phase 3 for metastatic renal cell carcinoma; development has stopped.","summary":"Rocapuldencel-T (AGS-003, AGS-003-LNG, AGS-003-BLD) is an individualised autologous dendritic cell immunotherapy (Arcelis platform) from Argos Therapeutics. An individualised immunotherapy made from the patient's own dendritic cells using the Arcelis platform; registry descriptions call it an RNA-transfected autologous dendritic cell vaccine (renal cell carcinoma/CD40L RNA). Its furthest stage is phase 3, for metastatic renal cell carcinoma. ClinicalTrials.gov registers it in 7 studies linked below. The ADAPT phase 3 IDMC recommended stopping for futility in February 2017; Argos continued, then discontinued ADAPT after an April 2018 interim analysis (10-Q filed 19 Nov 2018). Argos filed for chapter 11 on 30 November 2018 (8-K). Whether it works in people has not been established unless a trial below reports it.","status":"phase-3","asOf":"2026-11-03","links":[{"label":"Argos Therapeutics: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1105533/000117184318002425/f10k_040218p.htm"},{"label":"Argos Therapeutics: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1105533/000117184318008023/f10q_111918p.htm"},{"label":"Argos Therapeutics: sec.gov","url":"https://www.sec.gov/Archives/edgar/data/1105533/000117184318008263/f8k_113018.htm"},{"label":"Argos Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT01582672"},{"label":"ClinicalTrials.gov: trials of AGS-003","url":"https://clinicaltrials.gov/search?intr=AGS-003"}],"tags":["pipeline","ctgov-ingest","discontinued"],"related":[],"cancers":["rcc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["argos-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct01582672","nct00678119","nct00272649","nct01482949","nct02170389","nct02662634","nct02944357"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"AGS-003","modality":"Individualised autologous dendritic cell immunotherapy (Arcelis platform)","mechanism":"An individualised immunotherapy made from the patient's own dendritic cells using the Arcelis platform; registry descriptions call it an RNA-transfected autologous dendritic cell vaccine (renal cell carcinoma/CD40L RNA).","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/rocapuldencel-t/","neighbours":{"cancer":[{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"company":[{"id":"argos-therapeutics","kind":"company","name":"Argos Therapeutics","route":"/companies/argos-therapeutics/"}],"trial":[{"id":"nct01482949","kind":"trial","name":"A Rollover Protocol for Subjects Previously Treated With AGS-003","route":"/trials/nct01482949/"},{"id":"nct02662634","kind":"trial","name":"A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer","route":"/trials/nct02662634/"},{"id":"nct02944357","kind":"trial","name":"Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery","route":"/trials/nct02944357/"},{"id":"nct01582672","kind":"trial","name":"Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma","route":"/trials/nct01582672/"},{"id":"nct00678119","kind":"trial","name":"Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment","route":"/trials/nct00678119/"},{"id":"nct00272649","kind":"trial","name":"Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer","route":"/trials/nct00272649/"},{"id":"nct02170389","kind":"trial","name":"Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer","route":"/trials/nct02170389/"}]}}