ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer

NCT ID: NCT06810141

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).

Detailed Description

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Conditions

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NMIBC

Interventions

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rMBCG

1-19.2e8 colony-forming units (CFU) of rMBCG

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

1. Age ≥18 years old.
2. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
3. Ineligible to participate in a clinical trial using rMBCG or geographically unable to access a rMBCG clinical trial site.
4. 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. 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.
2. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ImmunityBio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology Centers of Alabama

Homewood, Alabama, United States

Site Status AVAILABLE

University Urology

Mobile, Alabama, United States

Site Status AVAILABLE

Urology Associates

Mobile, Alabama, United States

Site Status AVAILABLE

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status AVAILABLE

USC/ Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status AVAILABLE

Urology Center of Southern California

Murrieta, California, United States

Site Status AVAILABLE

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status AVAILABLE

Broward Urology Center

Fort Lauderdale, Florida, United States

Site Status AVAILABLE

Genesis Care

Fort Myers, Florida, United States

Site Status AVAILABLE

Cohen Urology

Lake Worth, Florida, United States

Site Status AVAILABLE

Sebring Urology Center

Sebring, Florida, United States

Site Status AVAILABLE

Florida Urology Partners

Tampa, Florida, United States

Site Status AVAILABLE

Albany Urology Clinic and Surgery Center

Albany, Georgia, United States

Site Status AVAILABLE

Emory University

Atlanta, Georgia, United States

Site Status AVAILABLE

Georgia Urology

Atlanta, Georgia, United States

Site Status AVAILABLE

Augusta Urology Associates, LLC

Evans, Georgia, United States

Site Status AVAILABLE

Hawaii Cancer Care

Honolulu, Hawaii, United States

Site Status AVAILABLE

Island Urology Oahu

Honolulu, Hawaii, United States

Site Status AVAILABLE

North Idaho Urology, PLLC

Coeur d'Alene, Idaho, United States

Site Status AVAILABLE

The Urology Clinic

Meridian, Idaho, United States

Site Status AVAILABLE

Advanced Urology Skokie

Skokie, Illinois, United States

Site Status AVAILABLE

Urology of Indiana

Carmel, Indiana, United States

Site Status AVAILABLE

US Urology Partners - Carmel

Greenwood, Indiana, United States

Site Status AVAILABLE

First Urology, P.S.C

Jeffersonville, Indiana, United States

Site Status AVAILABLE

Kansas City Urology Care, PA

Lenexa, Kansas, United States

Site Status AVAILABLE

Louisiana Healthcare Associates

Covington, Louisiana, United States

Site Status AVAILABLE

NRMC Urology Associates

Natchitoches, Louisiana, United States

Site Status AVAILABLE

Willis Knighton Urologic Oncology at Pierremont

Shreveport, Louisiana, United States

Site Status AVAILABLE

Pioneer Valley Urology, P.C.

Springfield, Massachusetts, United States

Site Status AVAILABLE

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status AVAILABLE

Comprehensive Urology

Waterford, Michigan, United States

Site Status AVAILABLE

Essentia Health - Duluth Clinic

Duluth, Minnesota, United States

Site Status AVAILABLE

Allina Health Cancer Institute- Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status AVAILABLE

Minnesota Urology

Woodbury, Minnesota, United States

Site Status AVAILABLE

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Site Status AVAILABLE

The Urology Center, P. C. D/B/A/ UroHealth Partners

Omaha, Nebraska, United States

Site Status AVAILABLE

University Urology of NJ

Hamilton, New Jersey, United States

Site Status AVAILABLE

Advance Urology Associates Enterprises/ HLP Urology Associates

Manasquan, New Jersey, United States

Site Status AVAILABLE

Garden State Urology

Morristown, New Jersey, United States

Site Status AVAILABLE

Capital Health Urology

Pennington, New Jersey, United States

Site Status AVAILABLE

Advanced Urology, Center for Robotic Surgery

Leland, North Carolina, United States

Site Status AVAILABLE

Cleveland Clinic

Garfield Heights, Ohio, United States

Site Status AVAILABLE

Department of Urology, Jefferson Einstein Hospital

Philadelphia, Pennsylvania, United States

Site Status AVAILABLE

Center for Urologic Care of Berks County

Wyomissing, Pennsylvania, United States

Site Status AVAILABLE

Urology Associates of Charleston

Mt. Pleasant, South Carolina, United States

Site Status AVAILABLE

AUC Urologists, LLC

Myrtle Beach, South Carolina, United States

Site Status AVAILABLE

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States

Site Status AVAILABLE

The University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status AVAILABLE

Rio Grande Urology

El Paso, Texas, United States

Site Status AVAILABLE

The Urology Place

San Antonio, Texas, United States

Site Status AVAILABLE

Danville Urologic Clinic

Danville, Virginia, United States

Site Status AVAILABLE

Potomac Urology

Fairfax, Virginia, United States

Site Status AVAILABLE

Valley Health Urology

Winchester, Virginia, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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Jayson Garmizo

Role: CONTACT

310-912-2230

Facility Contacts

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Meredith Sharpton

Role: primary

205-930-0902

Daisey Perez

Role: primary

858-822-5354

Irene Qazi

Role: primary

323-865-3081

Laura Guerrero

Role: primary

760-207-2560

Hiwot Guebre-Xabihner

Role: primary

202-877-9386

Role: primary

954-463-6408

Osvaldo Padron, MD

Role: primary

Caroline Branch

Role: primary

470-365-7728

Michelle Legrand

Role: primary

706-722-0705

Isobel Webster

Role: primary

808-524-6115 ext. 519

Role: primary

808-536-2306

Nicole Fox

Role: primary

208-667-0621

Laura Pazmino

Role: primary

208-991-6232

Role: primary

985-892-6811

Brenda Dickow

Role: primary

313-576-9372

Payton Kaiser

Role: primary

320-262-0594

Alex Alchev

Role: primary

651-999-6800

Shelby Nelson

Role: primary

402-399-7893

Nathalia Salazar

Role: primary

973-539-0333

Neena Shetty

Role: primary

609-394-4130

Sandy Pyland

Role: primary

910-641-8655

Christine Hubert

Role: primary

609-941-1162

Diane Hader

Role: primary

843-884-8045

Role: primary

843-839-1679

Linda Brantley

Role: primary

901-683-0055

Lauren Simpson

Role: primary

865-305-9254

Role: primary

210-617-3670

Renee Pickrel

Role: primary

434-792-1433

Megan Lloyd

Role: primary

540-667-1712

Other Identifiers

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ResQ132EX-NMIBC

Identifier Type: -

Identifier Source: org_study_id

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