Recombinant Mycobacterium for Bladder Cancer

Recruiting at 1 trial location

Overseen By Paula Bradshaw

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ImmunityBio, Inc.

Must not be taking: Steroids, Antibiotics, others

Disqualifiers: Heart failure, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with non-muscle invasive bladder cancer who haven't had BCG treatment. They should be in good enough health to perform daily activities (ECOG 0-2) and have a specific type of tumor after surgery. People can join if they've signed an agreement to follow the study rules.

Inclusion Criteria

My bladder cancer cannot be surgically removed, but I may have some remaining cancer cells.

I am able to care for myself and perform daily activities.

My bladder cancer has not invaded the muscle and I haven't had BCG treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an induction course of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) via a urinary catheter

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Intravesical Recombinant Mycobacterium (rMBCG)

Trial Overview The study tests a new form of intravesical therapy using Recombinant Mycobacterium Bacillus Calmette-Guérin (rMBCG) on patients with certain types of bladder tumors, comparing its safety and effectiveness against traditional treatments.

Participant Groups

Group I: Intravesical Recombinant Mycobacterium (rMBCG) Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

ImmunityBio, Inc.

Lead Sponsor

Trials

75

Recruited

5,000+

Richard Adcock

ImmunityBio, Inc.

Chief Executive Officer since 2024

Information not available

Dr. Patrick Soon-Shiong

ImmunityBio, Inc.

Chief Medical Officer since 2021

MD