Recombinant Mycobacterium for Bladder Cancer

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with non-muscle invasive bladder cancer. It uses a special type of bacteria, Recombinant Mycobacterium, administered directly into the bladder to determine its effectiveness against cancer cells. The trial seeks participants diagnosed with this type of bladder cancer who have not previously received similar treatment. Those who have undergone bladder cancer surgery but still have some cancer cells may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving other investigational or commercial anticancer agents or therapies for active disease.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the treatment, intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (rMBCG), is safe and generally well-tolerated. Previous studies indicate that most patients handle the treatment well. The treatment may also trigger an immune response that could help fight bladder cancer.

However, some patients in these studies experienced mild to moderate side effects. These side effects are usually manageable but should be discussed with a doctor.

Overall, safety data from earlier studies suggest that rMBCG is promising for use in humans. Joining a clinical trial involves working closely with medical professionals who will monitor health and address any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Unlike the standard treatments for bladder cancer, such as Bacillus Calmette-Guérin (BCG) immunotherapy and chemotherapy, the intravesical recombinant Mycobacterium (rMBCG) offers a novel approach. Researchers are excited because rMBCG is a genetically modified bacterium designed to enhance the immune response specifically within the bladder. This unique mechanism could potentially lead to a more effective and targeted reaction against cancer cells, reducing side effects associated with traditional therapies. Plus, its direct delivery into the bladder through a urinary catheter ensures that the treatment acts precisely where it's needed most.

What evidence suggests that this treatment might be an effective treatment for bladder cancer?

Research has shown that intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (rMBCG), which participants in this trial will receive, may help treat non-muscle invasive bladder cancer (NMIBC). One study found that nearly half of the patients (46%) did not experience cancer recurrence within two years. The treatment was generally well-tolerated, with only 4% of patients experiencing cancer progression. This treatment boosts the immune system to fight cancer cells. While more research is needed, these results suggest that rMBCG could be a promising option for patients with NMIBC. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

I agree to participate in the study and follow all its requirements.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10331337/

Evaluating the Effectiveness of Intravesical Instillation ... Results: Although the recurrence rate was lower in group I (16.7% vs 31%), there was no significant difference among groups (P = .124) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06800963

Study Details | NCT06800963 | ResQ133A-NMIBC ... This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S030228382500123X

A Systematic Review of Novel Intravesical Approaches for ... They found a 2-yr RFS rate of 46% with excellent tolerability and a low rate of progression (4% on transurethral resection of a bladder tumor [TURBT] and 4% at ...

4. web-api.polscientific.com web-api.polscientific.com/uploads/file/asp/20250530144611debbc5670.pdf

Advances in recombinant Bacillus Calmette–Guérin ... This review highlights recent advancements in rBCG therapy from 2015 to 2024, focusing on cytokine production and bacteriological mechanisms.

5. tandfonline.com tandfonline.com/doi/full/10.1080/2162402X.2020.1748981

Results of the phase I open label clinical trial SAKK 06/14 ... Conclusion: The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response. KEYWORDS:.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32363120/

Results of the phase I open label clinical trial SAKK 06/14 ... The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response.