NCT06800963

Brief 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 primary or recurrent stage Ta and/or T1 papillary tumors following Transurethral resection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
21mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Oct 2025Feb 2028

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 27, 2026

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

January 24, 2025

Last Update Submit

March 26, 2026

Conditions

NMIBC

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approximately 7 months

Study Arms (1)

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).

Biological: Intravesical Recombinant Mycobacterium (rMBCG)

Interventions

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)

Intravesical Recombinant Mycobacterium (rMBCG)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Arizona Clinical Trials

Chandler, Arizona, 85224, United States

NOT YET RECRUITING

Golden State Urology

Sacramento, California, 95823, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Michigan Institute of Urology & Solaris Health

Troy, Michigan, 48084, United States

RECRUITING

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

NOT YET RECRUITING

MidLantic Urology

Cynwyd, Pennsylvania, 19004, United States

RECRUITING

Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

NOT YET RECRUITING

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

RECRUITING

Potamac Urology Center

Alexandria, Virginia, 22311, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Jayson Garmizo

CONTACT

310-912-2230jayson.garmizo@immunitybio.com

Natalie Fernandez

CONTACT

Natalie.Fernandez@Immunitybio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

March 27, 2026

Record last verified: 2025-09

Locations

US(9)