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rBCG

Phase 1

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

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

Clinical trial landscape

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
NMIBC
NCT0680096340
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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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