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

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).

NCT Number	NCT06829823
Lead Sponsor	ImmunityBio, Inc.
Conditions	Non-muscle Invasive Bladder Cancer (NMIBC)
Enrollment	20 participants
Start Date	2025-11
Primary Completion	2026-11 (estimated)
Study Completion	2029-11 (estimated)
Updated on ClinicalTrials.gov	2025-10-16