OncoMatch/Clinical Trials/NCT06800963
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
Is NCT06800963 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Intravesical Recombinant Mycobacterium (rMBCG) for nmibc.
Treatment: Intravesical Recombinant Mycobacterium (rMBCG) — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage CIS
Excluded: Stage MUSCLE-INVASIVE, III, IV, EXTRAVESICAL
histologically confirmed presence of NMIBC CIS (with or without Ta/T1 papillary disease) OR primary or recurrent stage Ta and/or T1 papillary tumors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anticancer therapy
Exception: other than rMBCG and supportive care therapies for active disease
Participants currently receiving investigational or commercial anticancer agents or anticancer therapies other than rMBCG and supportive care therapies for active disease
Lab requirements
Blood counts
ANC <800/μL; Platelets <50,000/μL
Kidney function
Renal insufficiency as indicated by a creatinine level >3 X ULN
Liver function
Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or ALT) > 2 X ULN
Cardiac function
Symptomatic congestive heart failure (NYHA Class III or IV) or other clinical signs of severe cardiac dysfunction; severe/unstable angina pectoris; myocardial infarction within 6 months prior to study entry
Any of the following clinical laboratory values at the time of enrollment: ANC <800/μL; Platelets <50,000/μL; Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or ALT) > 2 X ULN; Renal insufficiency as indicated by a creatinine level >3 X ULN. Symptomatic congestive heart failure (CHF), NYHA Class III or IV heart failure or other clinical signs of severe cardiac dysfunction. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Clinical Trials · Chandler, Arizona
- Golden State Urology · Sacramento, California
- Emory University · Atlanta, Georgia
- Michigan Institute of Urology & Solaris Health · Troy, Michigan
- SUNY Upstate Medical University · Syracuse, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify