NCT06829823

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

Phase 2 Clinical Trial of Ablation Therapy With Intravesical N-803 In Combination With BCG or Gemcitabine in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

Type	Name	Description
DRUG	N-803 and BCG	Combination therapy N-803 plus BCG
DRUG	N-803 and Gemcitabine	Combination therapy N-803 plus Gemcitabine

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-11-01
• Completion: 2029-11-01
• First posted: 2025-02-17
• Last updated: 2025-10-16

Regulatory

• FDA-regulated drug study