Actively Recruiting
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
Led by ImmunityBio, Inc. · Updated on 2026-03-27
40
Participants Needed
9
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18 years of age or older
- Histologic confirmation of BCG na�ve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant) AND either presence of NMIBC CIS (with or without Ta/T1 papillary disease) OR primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection
- Absence of resectable disease after TURBT procedures (residual CIS acceptable; repeat resection and biopsy required for T1 tumors if initial biopsy did not include muscularis propria)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations
You will not qualify if you...
- Life expectancy less than 2 years
- Absolute neutrophil count (ANC) less than 800/bcL
- Platelets less than 50,000/bcL
- Liver enzyme elevation (AST or ALT) greater than 2 times upper limit of normal
- Renal insufficiency indicated by creatinine level greater than 3 times upper limit of normal
- History or evidence of muscle-invasive, locally advanced, metastatic or extravesical bladder cancer or cancer within past 5 years requiring active treatment, except certain treated skin or cervical cancers or stable prostate cancer under surveillance
- Symptomatic congestive heart failure (NYHA Class III or IV) or severe cardiac dysfunction
- Severe or unstable angina or myocardial infarction within 6 months prior to study entry
- History or evidence of uncontrollable central nervous system disease
- Active systemic infection requiring intravenous antibiotics
- Concurrent febrile illness, active urinary tract infection, active tuberculosis, history of hypotension or anaphylactic reactions
- Ongoing chronic systemic steroid therapy (>10 mg oral prednisone daily or equivalent)
- Women who are pregnant or nursing; women of childbearing potential must have a negative pregnancy test and use birth control during and 30 days after study; males must use barrier birth control during and 90 days after study
- Participants currently receiving other anticancer agents or investigational therapies except rMBCG and supportive care
- Concurrent use of other investigational agents (excluding FDA authorized COVID-19 drugs)
- Other illnesses or conditions, including lab abnormalities or psychiatric illness, that may interfere with participation as judged by the Investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Arizona Clinical Trials
Chandler, Arizona, United States, 85224
Not Yet Recruiting
2
Golden State Urology
Sacramento, California, United States, 95823
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Michigan Institute of Urology & Solaris Health
Troy, Michigan, United States, 48084
Actively Recruiting
5
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Not Yet Recruiting
6
MidLantic Urology
Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
7
Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Not Yet Recruiting
8
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
9
Potamac Urology Center
Alexandria, Virginia, United States, 22311
Not Yet Recruiting
Research Team
J
Jayson Garmizo
CONTACT
N
Natalie Fernandez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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