N-803 + BCG for Bladder Cancer

Recruiting at 29 trial locations

Overseen By Andrew Trainer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: ImmunityBio, Inc.

Must be taking: BCG

Must not be taking: Systemic steroids

Disqualifiers: Life expectancy <2 years, Liver abnormalities, Renal insufficiency, Severe cardiac dysfunction, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

190 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.

Research Team

Karim Chamie, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Adults over 18 with high-grade non-muscle invasive bladder cancer unresponsive to BCG treatment can join. They must have had specific prior treatments, no resectable disease after surgery, and an ECOG status of 0-2. Exclusions include life expectancy under 2 years, certain heart conditions, active infections or recent severe infections, ongoing steroid therapy above a set dose, other cancer treatments or investigational drugs (excluding COVID-19), serious medical or psychiatric issues that could affect participation.

Inclusion Criteria

My bladder cancer cannot be removed by surgery, but I've had all necessary resections.

I can take care of myself and am up and about more than half of my waking hours.

Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Exclusion Criteria

Your blood test results show low levels of white blood cells or platelets.

My liver enzymes are more than twice the normal limit.

I do not have uncontrollable brain or nervous system disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Induction Treatment

Participants receive BCG plus N-803 or N-803 only weekly for 6 consecutive weeks

6 weeks

Second Treatment Period

Eligible patients receive either a 3-week maintenance course or a 6-week re-induction course at Month 3

3-6 weeks

Third Treatment Period

Eligible patients continue to receive maintenance treatment at Months 6, 9, 12, and 18

12 months

Fourth Treatment Period (Optional)

Eligible patients have the option to receive maintenance treatment at Months 24, 30, and 36

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• BCG
• N-803

Trial Overview The trial is testing the effectiveness of intravesical BCG combined with N-803 versus N-803 alone in treating bladder cancer that hasn't responded to previous BCG therapy. Patients receive these treatments through a urinary catheter for six weeks initially and may continue maintenance treatment at various intervals up to three years if eligible.

Participant Groups

Group I: BCG+N-803 Experimental Treatment 2 Interventions

BCG is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Bacillus Calmette-Guérin for:

• Non-muscle invasive bladder cancer

Approved in European Union as Bacillus Calmette-Guérin for:

• Non-muscle invasive bladder cancer

Approved in Canada as Bacillus Calmette-Guérin for:

• Non-muscle invasive bladder cancer

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