Actively Recruiting
ResQ133A-NMIBC: Phase 1/2 Clinical Trial of 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating intravesical Recombinant Mycobacterium Bacillus Calmette-Gu e9rin (rMBCG) in adults with non-muscle invasive bladder cancer (NMIBC) who have not previously received BCG treatment. This phase 1/2, open-label, multicenter study focuses on participants with confirmed carcinoma in situ (CIS) or primary/recurrent stage Ta and/or T1 papillary tumors following transurethral resection. The study aims to assess the safety and effects of this biological treatment in this patient group. Participants will receive an induction course of rMBCG administered directly into the bladder via a urinary catheter. The dose consists of 1 vial containing 19.2e8 colony-forming units (CFU) delivered intravesically. This single-arm study monitors participants through the treatment phase to evaluate safety outcomes over approximately seven months. During the study, participants will be closely monitored for safety by tracking the incidence and severity of adverse events. Evaluations include clinical assessments and laboratory tests at regular intervals. Participants must provide written consent and agree to comply with study procedures and follow-up evaluations. The total duration includes the treatment period and safety observation lasting about seven months.
CONDITIONS
Brief 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 naive non-muscle invasive urothelial carcinoma of the bladder
- Presence of NMIBC carcinoma in situ (CIS) with or without Ta/T1 papillary disease, or primary/recurrent stage Ta and/or T1 papillary tumors after transurethral resection
- No resectable disease after transurethral resection of bladder tumor (TURBT); residual CIS acceptable
- ECOG performance status of 0, 1, or 2
- Voluntary written informed consent and agreement to comply with all study 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
- Platelet count less than 50,000/bcL
- Liver enzyme elevation (AST or ALT) greater than 2 times upper limit of normal
- Creatinine level greater than 3 times upper limit of normal
- History or evidence of muscle-invasive, locally advanced, metastatic, or extravesical bladder cancer
- Other active cancers within the past 5 years requiring treatment, with certain exceptions
- Severe cardiac conditions including symptomatic congestive heart failure NYHA Class III or IV, unstable angina, or recent myocardial infarction
- Uncontrollable central nervous system disease
- Active systemic infection needing parenteral antibiotics or unresolved infections
- Concurrent febrile illness, active urinary tract infection, active tuberculosis
- History of hypotension or anaphylactic reactions
- Ongoing chronic systemic steroid therapy over 10 mg oral prednisone daily or equivalent
- Pregnant or nursing women; women of childbearing potential must have negative pregnancy test and use birth control
- Males must agree to use barrier contraception during and 90 days after treatment
- Current use of other investigational or commercial anticancer agents except rMBCG and supportive care
- Concurrent use of other investigational agents (excluding authorized COVID-19 drugs)
- Other serious medical or psychiatric conditions that may interfere with participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 months
Participants will receive an induction course of intravesical recombinant Mycobacterium (rMBCG) administered via urinary catheter into the bladder.
Visits as needed for treatment administration and safety monitoring
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
N
Natalie Fernandez
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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