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

Phase 1/2 Active not recruiting 369 enrolled ImmunityBio, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-07-21
Primary completion: 2026-09-30
Completion: 2039-03-04

Publications

Chamie K, Chang SS, Rosser CJ, Kramolowski E, Gonzalgo ML, Sexton WJ, Spilman P, Sender L, Reddy S, Soon-Shiong P. N-803 Plus BCG Treatment for BCG-Naive or -Unresponsive Non-Muscle Invasive Bladder Cancer: A Plain Language Review. Future Oncol. 2024;20(31):2307-2317. doi: 10.1080/14796694.2024.2363744. Epub 2024 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BCG	Unknown	50 mg	Intravenous
Subject	N-803	Protein / enzyme biologic	100 ug	Intravenous
Subject	N-803	Protein / enzyme biologic	200 ug	Intravenous
Subject	N-803	Protein / enzyme biologic	400 ug	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications