Clinical Trial

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

Active, Not Recruiting Phase 1/2
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Summary
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-01
notable Enrollment reduced: 596 -> 369 participants 2026-04-01
notable Primary completion moved earlier: 2028-12 -> 2026-09-30 2026-04-01
minor Completion pushed: 2038-12 -> 2039-03-04 2026-04-01
Trial Details
NCT Number NCT02138734
Lead Sponsor ImmunityBio, Inc.
Conditions Non-muscle Invasive Bladder Cancer
Enrollment 369 participants
Start Date 2014-07-21
Primary Completion 2026-09-30 (estimated)
Study Completion 2039-03-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-31