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

March 26, 2026 updated by: ImmunityBio, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Not yet recruiting
        • Arizona Clinical Trials
        • Contact:
        • Principal Investigator:
          • Patel Pratik, MD
    • California
      • Sacramento, California, United States, 95823
        • Recruiting
        • Golden State Urology
        • Principal Investigator:
          • Prithipal Sethi, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Shreyas Joshi, MD
        • Contact:
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology & Solaris Health
        • Principal Investigator:
          • Jason Hafron, MD
        • Contact:
    • New York
      • Syracuse, New York, United States, 13210
        • Not yet recruiting
        • SUNY Upstate Medical University
        • Principal Investigator:
          • Joseph Jacob, MD
        • Contact:
    • Pennsylvania
      • Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology
        • Contact:
          • Catherine Frye
          • Phone Number: 610-667-0458
        • Principal Investigator:
          • Lawrence Belkoff, DO
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Not yet recruiting
        • Conrad Pearson Clinic
        • Principal Investigator:
          • Ravi Chauhan, MD
        • Contact:
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates, P.C.
        • Principal Investigator:
          • Gautam Jayram, MD
        • Contact:
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Not yet recruiting
        • Potamac Urology Center
        • Principal Investigator:
          • Aseem Malhotra, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet ALL of the following criteria for inclusion in the study:

  1. Male or female participants 18 years of age or older.
  2. 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).
  3. 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).
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  5. Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.

Exclusion Criteria:

Participants with ANY of the following criteria are excluded from participation in the study:

  1. Life expectancy <2 years

  2. Any of the following clinical laboratory values at the time of enrollment:

    1. Absolute neutrophil count (ANC) <800/μL
    2. Platelets < 50,000/μL
    3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 2 X upper limit of normal (ULN)
    4. Renal insufficiency as indicated by a creatinine level >3 X ULN
  3. 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.
  4. Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction.
  5. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
  6. History or evidence of uncontrollable central nervous system disease.
  7. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
  8. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
  9. Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or equivalent).
  10. 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.
  11. Participants currently receiving investigational or commercial anticancer agents or anticancer therapies other than rMBCG and supportive care therapies for active disease.
  12. Concurrent use of other investigational agents (not including FDA authorized drugs for the prevention and treatment of COVID-19).
  13. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunityBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ResQ133A-NMIBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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