NCT06800963

ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG

ResQ133A-NMIBC: Phase 1/2 Clinical Trial of Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

• NMIBC

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-10-15
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-01-30
• Last updated: 2026-03-27

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study