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

NCT ID: NCT05981131

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2033-08-30

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Enrolled and treated with intravesical N-803 plus BCG in the phase 1b portion of QUILT-2.005.

Exclusion Criteria

• Not applicable

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmunityBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobby Reddy, MD

Role: STUDY_DIRECTOR

ImmunityBio, Inc.

Locations

Island Urology

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

QUILT-205

Identifier Type: -

Identifier Source: org_study_id