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NOT YET RECRUITING
NCT06829823
PHASE2

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

Sponsor: ImmunityBio, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-11

Completion Date

2029-11

Last Updated

2025-10-16

Healthy Volunteers

No

Interventions

DRUG

N-803 and BCG

Combination therapy N-803 plus BCG

DRUG

N-803 and Gemcitabine

Combination therapy N-803 plus Gemcitabine