drugset / Trial / NCT06829823

Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

NCT06829823

Phase 2 Not yet recruiting 20 enrolled ImmunityBio, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).

Timeline

Start
2025-11
Primary completion
2026-11
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG Unknown 50 mg Intravenous
Subject Gemcitabine Small molecule 2000 mg Intravenous
Subject N-803 Protein / enzyme biologic 400 ug Intravenous