NMIBCPhase 1/2NCT06800963
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
A Phase 1/2 study testing Intravesical Recombinant Mycobacterium (rMBCG) in people with NMIBC, run by ImmunityBio, Inc. at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- NMIBC
- What is being tested?
- Intravesical Recombinant Mycobacterium (rMBCG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Oct 2025to Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet ALL of the following criteria for inclusion in the study:
- Male or female participants 18 years of age or older.
- Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed presence of NMIBC CIS (with or without Ta/T1 papillary disease) OR ii) primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
- Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] of the T1 tumor site 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.
Who cannot join
- Participants with ANY of the following criteria are excluded from participation in the study:
- Life expectancy <2 years
- Any of the following clinical laboratory values at the time of enrollment:
- Absolute neutrophil count (ANC) <800/μL
- Platelets < 50,000/μL
- Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2 X upper limit of normal (ULN)
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- Renal insufficiency as indicated by a creatinine level >3 X ULN
- History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; and adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission, and is under active surveillance or hormone control.
- Symptomatic congestive heart failure (CHF), New York Heart Association (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.
- History or evidence of uncontrollable central nervous system disease.
- Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
- Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
- Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or equivalent).
- Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.
- Participants currently receiving investigational or commercial anticancer agents or anticancer therapies other than rMBCG and supportive care therapies for active disease.
- Concurrent use of other investigational agents (not including FDA authorized drugs for the prevention and treatment of COVID-19).
- Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Natalie Fernandez contact
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
Potamac Urology Center
Alexandria, Virginia, 22311
Morgan Gray, 703-680-2111, morgan.gray@potomacurology.com
Aseem Malhotra, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
Fana Cisse, 404-778-0897, fana.cisse@emory.edu
Shreyas Joshi, MD
- Not yet recruiting
Arizona Clinical Trials
Chandler, Arizona, 85224
Rajinder Kaur, MD, 480-605-443, rkaur@azclinicaltrials.com
Patel Pratik, MD
- Recruiting
MidLantic Urology
Cynwyd, Pennsylvania, 19004
Catherine Frye, 610-667-0458
Lawrence Belkoff, DO
- Not yet recruiting
Conrad Pearson Clinic
Germantown, Tennessee, 38138
Russ Grigsby, 901-236-0957, russell.grigsby@conradpearson.com
Ravi Chauhan, MD
- Recruiting
Urology Associates, P.C.
Nashville, Tennessee, 37209
Nathaniel Kelly, 615-250-9284, ndkelly@ua-pc.com
Gautam Jayram, MD
- Recruiting
Golden State Urology
Sacramento, California, 95823
Sehaj Sethi, 916-245-8888, ssethi@goldenstateurology.com
Prithipal Sethi, MD
- Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Nicholas Carusone, 315-464-5296, carusonn@upstate.edu
Joseph Jacob, MD
- Recruiting
Michigan Institute of Urology & Solaris Health
Troy, Michigan, 48084
Kristin Smith, 248-786-0467 ext. 2835, smithkr@michiganurology.com
Jason Hafron, MD
About this study
Official title: ResQ133A-NMIBC: Phase 1/2 Clinical Trial of Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
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
- Being tested
- Intravesical Recombinant Mycobacterium (rMBCG)
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical Recombinant Mycobacterium (rMBCG)Biological
19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration)
| Study group | Role | What they receive |
|---|---|---|
| Intravesical Recombinant Mycobacterium (rMBCG) | Experimental | Participants will receive an induction course of 1-19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration). Receives: Biological: Intravesical Recombinant Mycobacterium (rMBCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to assess safety as measured by the incidence and severity of adverse events.
Safety assessments will include demographics/medical history, vital signs, hematology, chemistry, urinalysis, and pregnancy.
Measured: Approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start15 Oct 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800963
- Sponsor's protocol ID
- ResQ133A-NMIBC
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ResQ133A-NMIBC: Phase 1/2 Clinical Trial of Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
- ClinicalTrials.gov ID
- NCT06800963
- Acronym / sponsor ID
- ResQ133A-NMIBC
- Conditions
- NMIBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical Recombinant Mycobacterium (rMBCG) | Experimental | Biological: Intravesical Recombinant Mycobacterium (rMBCG)Participants will receive an induction course of 1-19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants 18 years of age or older.
- Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed presence of NMIBC CIS (with or without Ta/T1 papillary disease) OR ii) primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
- Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] of the T1 tumor site 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.
Key exclusion criteria (18 listed)
- Participants with ANY of the following criteria are excluded from participation in the study:
- Life expectancy <2 years
- Any of the following clinical laboratory values at the time of enrollment:
- History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; and adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission, and is under active surveillance or hormone control.
- Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical Recombinant Mycobacterium (rMBCG)19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration) | Biological | Intravesical Recombinant Mycobacterium (rMBCG) |
Primary outcome
The primary endpoint is to assess safety as measured by the incidence and severity of adverse events.
Time frame: Approximately 7 months
Safety assessments will include demographics/medical history, vital signs, hematology, chemistry, urinalysis, and pregnancy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Fernandez contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravesical Recombinant Mycobacterium (rMBCG) in people with NMIBC, run by ImmunityBio, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayson Garmizo (310-912-2230, jayson.garmizo@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is to assess safety as measured by the incidence and severity of adverse events. (time frame: Approximately 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.