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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
ImmunityBio, Inc.
Study ID
NCT06800963
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Oct 15, 2025
Status verified
Sep 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

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 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Arizona Clinical TrialsChandlerArizona85224
Rajinder Kaur, MD
[email protected]
480-605-443
Patel Pratik, MD (PRINCIPAL_INVESTIGATOR)
Golden State UrologySacramentoCalifornia95823
Sehaj Sethi
[email protected]
916-245-8888
Prithipal Sethi, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Fana Cisse
[email protected]
404-778-0897
Shreyas Joshi, MD (PRINCIPAL_INVESTIGATOR)
Michigan Institute of Urology & Solaris HealthTroyMichigan48084
Kristin Smith
[email protected]
248-786-0467
Jason Hafron, MD (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210
Nicholas Carusone
[email protected]
315-464-5296
Joseph Jacob, MD (PRINCIPAL_INVESTIGATOR)
MidLantic UrologyCynwydPennsylvania19004
Catherine Frye
610-667-0458
Lawrence Belkoff, DO (PRINCIPAL_INVESTIGATOR)
Conrad Pearson ClinicGermantownTennessee38138
Russ Grigsby
[email protected]
901-236-0957
Ravi Chauhan, MD (PRINCIPAL_INVESTIGATOR)
Urology Associates, P.C.NashvilleTennessee37209
Nathaniel Kelly
[email protected]
615-250-9284
Gautam Jayram, MD (PRINCIPAL_INVESTIGATOR)
Potamac Urology CenterAlexandriaVirginia22311
Morgan Gray
[email protected]
703-680-2111
Aseem Malhotra, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chandler, AZ

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Arizona Clinical Trials· Chandler, AZGolden State Urology· Sacramento, CAEmory University· Atlanta, GAMichigan Institute of Urology & Solaris Health· Troy, MISUNY Upstate Medical University· Syracuse, NYMidLantic Urology· Cynwyd, PA

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