ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
NCT06800963 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-03-27
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.
Conditions
Interventions
- BIOLOGICAL
-
Intravesical Recombinant Mycobacterium (rMBCG)
19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration)
Sponsors & Collaborators
-
ImmunityBio, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-15
- Primary Completion
- 2028-02-29
- Completion
- 2028-02-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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