NCT05981131

Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)

QUILT-205: Long-Term Follow-Up of Subjects in QUILT-2.005 Phase 1b Trial of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the QUILT-2.005 study.

Detailed description

All 9 subjects that completed QUILT-2.005 phase 1b are planned to be enrolled in this study. Thus, the maximum enrollment for this study is 9 subjects. All enrolled subjects will be followed every 12 months for life, or until withdrawal of consent, or if the Sponsor closes the study.

Conditions

• Non Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	N803 plus Bacillus Calmette-Guerin (BCG)	QUILT-2.005 phase 1b (NCT02138734) was an open-label, dose-escalation, multicenter study of intravesical Bacillus Calmette-Guerin (BCG) plus N-803 in BCG-naïve non muscle invasive bladder cancer (NMIBC). A modified 3 + 3 design was used. Three subjects were enrolled at each dose level starting at 100 μg/instillation of N-803 and subsequently increasing to 200 μg/instillation and 400 μg/instillation. A standard dose of BCG, 50 mg, was employed. The primary endpoints of the study were: determination of the maximum tolerated dose (MTD) and designation of the recommended dose (RD) of N-803 in combination with BCG in subjects who have BCG-naïve NMIBC; safety profile of N-803 plus BCG in treated subjects; and disease response rate in treated subjects. A total of 9 subjects with high-risk, high-grade, BCG-naïve, NMIBC were enrolled into 3 cohorts and treated by intravesical administration of N-803 plus BCG.

Timeline

• Start date: 2023-08-17
• Primary completion: 2033-08-30
• Completion: 2033-08-30
• First posted: 2023-08-08
• Last updated: 2025-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study