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rBCG

Phase 1

NMIBC | Monoclonal antibody | Oncology |ImmunityBio, Inc.|Trials Updated: Mar 27, 2026

rBCG target and mechanism

ModalityMonoclonal antibody

Also known as Intravesical Recombinant Mycobacterium (rMBCG), Intravesical Recombinant Mycobacterium

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

rBCG clinical trials

rBCG · 1 trial · 1 indication

Phase 1 1
NCT06800963ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCGNMIBC
RECRUITING40 Analytics
PHASE1RECRUITING
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
NMIBCUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint is to assess safety as measured by the incidence and severity of adverse events.
Approximately 7 months

Safety assessments will include demographics/medical history, vital signs, hematology, chemistry, urinalysis, and pregnancy.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intravesical Recombinant Mycobacterium (rMBCG)EXPERIMENTALParticipants 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).

Interventions

NameTypeDescription
Intravesical Recombinant Mycobacterium (rMBCG)BIOLOGICAL19.2e8 Colony-forming unit(s) CFU (1 vial) rMBCG via a urinary catheter in the bladder (ie, intravesical administration)
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites9

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 urothelia...

Countries:United States
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Frequently asked questions about rBCG

What is rBCG?

rBCG is an investigational intravesical recombinant Mycobacterium therapy being developed by ImmunityBio, Inc. for non-muscle invasive bladder cancer (NMIBC). It is designed to be given directly into the bladder and is currently in Phase 1 clinical development. It is also known as Intravesical Recombinant Mycobacterium (rMBCG).

What is rBCG used for in NMIBC?

rBCG is being studied for non-muscle invasive bladder cancer (NMIBC) in patients who are eligible to receive intravesical Tice BCG. It is an intravesical recombinant Mycobacterium therapy given directly into the bladder. The program is in Phase 1 development and is not approved for any indication.

Who is developing rBCG?

rBCG is being developed by ImmunityBio, Inc., which trades under the ticker IBRX. The company is running the Phase 1 ResQ133A-NMIBC study of intravesical recombinant Mycobacterium (rMBCG) in participants with NMIBC who are eligible to receive intravesical Tice BCG.

What phase is rBCG in?

rBCG is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The only registered trial is a Phase 1 study in NMIBC, and it is currently recruiting participants.

What clinical trials is rBCG in?

rBCG is being evaluated in the Phase 1 ResQ133A-NMIBC trial, registered as NCT06800963. The study is recruiting up to 40 participants with NMIBC who are eligible to receive intravesical Tice BCG. It is an uncontrolled, non-randomized, open-label study enrolling adults aged 18 years and older in the United States.

Is rBCG the same as Intravesical Recombinant Mycobacterium?

Yes. rBCG is also known as Intravesical Recombinant Mycobacterium (rMBCG) and Intravesical Recombinant Mycobacterium. These names refer to the same investigational agent developed by ImmunityBio, Inc. for non-muscle invasive bladder cancer, so searches under any of these names point to the same Phase 1 program.