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

NCT05981131 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Non Muscle Invasive Bladder Cancer

Interventions

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.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Bobby Reddy, MD · ImmunityBio, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2033-08-30
Completion
2033-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981131 on ClinicalTrials.gov