ResQ133A-NMIBC: Phase 1/2 Clinical Trial of Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
ImmunityBio, Inc.
Summary
This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guérin and have histologically confirmed presence of Carcinoma in situ (CIS) or have primary or recurrent stage Ta and/or T1 papillary tumors following Transurethral resection.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants must meet ALL of the following criteria for inclusion in the study: 1. Male or female participants 18 years of age or older. 2. Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed presence of NMIBC CIS (with or without Ta/T1 papillary disease) OR ii) primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). 3. Absence of resectable disease after TURBT procedure…
Interventions
- BiologicalIntravesical Recombinant Mycobacterium (rMBCG)
19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration)
Locations (9)
- Arizona Clinical TrialsChandler, Arizona
- Golden State UrologySacramento, California
- Emory UniversityAtlanta, Georgia
- Michigan Institute of Urology & Solaris HealthTroy, Michigan
- SUNY Upstate Medical UniversitySyracuse, New York
- MidLantic UrologyCynwyd, Pennsylvania