596 Participants Needed

BCG + N-803 for Bladder Cancer

Recruiting at 13 trial locations
EH
LH
PB
AH
Overseen ByAtessa H Kiani, BS
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: ImmunityBio, Inc.
Must be taking: BCG therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic systemic steroid therapy or investigational agents, you may need to stop those before participating.

Is the BCG + N-803 treatment for bladder cancer safe for humans?

The treatment involving N-803, a chimeric IL-15 superagonist, has been tested in healthy human volunteers and was well tolerated, with no serious adverse events reported. Common side effects included injection site reactions, chills, and fever. Additionally, IL-15-based treatments have shown no severe adverse events in cancer patients, suggesting a favorable safety profile.12345

What makes the BCG + N-803 treatment unique for bladder cancer?

The BCG + N-803 treatment is unique because it combines Bacillus Calmette-Guérin (BCG) with N-803, an IL-15 superagonist, to enhance the immune response against bladder cancer. This combination has shown to significantly reduce tumor burden and improve long-term disease-free survival by boosting the activity of natural killer (NK) cells and CD8+ T cells, which are crucial for attacking cancer cells.34678

What data supports the effectiveness of the drug BCG + N-803 for bladder cancer?

Research shows that combining BCG with IL-15, a component of N-803, enhances the immune response against bladder cancer by increasing the activity of immune cells like natural killer (NK) cells and CD8+ T cells, which are crucial for fighting tumors. Additionally, IL-15 has been shown to work well with other cancer treatments, suggesting it could be effective in combination therapies for bladder cancer.348910

Who Is on the Research Team?

BR

Bobby Reddy, MD

Principal Investigator

ImmunityBio, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with high-grade non-muscle invasive bladder cancer who haven't had BCG treatment before. They should be in good enough health to undergo the therapy, with specific blood counts and organ functions within set limits. Women of childbearing age must use birth control, as must men, to prevent pregnancy during the study.

Inclusion Criteria

You had an imaging test of your upper body within the last 6 months, and it did not show signs of cancer in that area.
Laboratory tests performed within 21 days of treatment start: Absolute neutrophil count (AGC/ANC) ≥ 1,000/µL, Platelets ≥ 100,000/µL, Hemoglobin ≥ 8 g/dL, Calculated glomerular filtration rate (GFR*) >40 mL/min or Serum creatinine ≤ 1.5 x ULN, Total bilirubin ≤ 2.0 X ULN, AST, ALT, ALP ≤ 3.0 X ULN, Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction, Negative serum pregnancy test if female and of childbearing potential, Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized, Male participants must agree to use barrier methods of birth control while on study, Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
My bladder cancer is confirmed to be high-grade and not muscle-invasive.
See 4 more

Exclusion Criteria

You have been diagnosed with HIV.
You are not using any other experimental drugs at the same time.
I haven't had bladder or any cancer except specific cases in the last 5 years.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase Ib)

Patients are treated with intravesical N-803 in combination with BCG to evaluate safety and determine the Maximum Tolerated Dose (MTD) and Recommended Dose (RD) level.

6 months

Expansion (Phase IIb)

Patients are randomized to receive either intravesical N-803 in combination with BCG or BCG alone to evaluate treatment efficacy.

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including long-term follow-up data collection.

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • ALT-803
  • BCG
Trial Overview The study compares two treatments: one group receives a combination of an immune response booster called N-803 plus BCG (a type of immunotherapy), while another group gets only BCG. It's designed to see if adding N-803 improves outcomes for patients who are new to this kind of treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: N-803+BCGExperimental Treatment1 Intervention
(Phase Ib and IIb) for BCG-naive patients
Group II: BCG aloneActive Control1 Intervention
(Phase IIb) for BCG-naive patients

ALT-803 is already approved in United States for the following indications:

🇺🇸
Approved in United States as Anktiva for:
  • Non-muscle invasive bladder cancer

Find a Clinic Near You

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

Published Research Related to This Trial

BCG-IL-15 treatment significantly improved survival rates in mice with bladder cancer compared to standard BCG treatment, indicating enhanced efficacy in cancer therapy.
The BCG-IL-15 strain increased neutrophil infiltration and elevated chemokine levels in the bladder, suggesting that it may enhance the immune response against bladder tumors.
Antitumor activity of recombinant Bacille Calmette-Guérin secreting interleukin-15-Ag85B fusion protein against bladder cancer.Takeuchi, A., Eto, M., Tatsugami, K., et al.[2017]
IL-15SA/IL-15RαSu-Fc significantly expanded natural killer (NK) and CD8+ T cells in tumor-bearing mice, enhancing their anti-tumor functions and leading to prolonged survival.
The treatment showed notable anti-tumor activity against metastases in breast and colon cancer models, especially when combined with checkpoint inhibitors, indicating its potential as an effective immunotherapy strategy.
IL-15 superagonist/IL-15RαSushi-Fc fusion complex (IL-15SA/IL-15RαSu-Fc; ALT-803) markedly enhances specific subpopulations of NK and memory CD8+ T cells, and mediates potent anti-tumor activity against murine breast and colon carcinomas.Kim, PS., Kwilas, AR., Xu, W., et al.[2021]
The study highlights the critical role of the IL-15 pathway in enhancing the effectiveness of CD40 agonist antibodies in treating bladder cancer, particularly by increasing the activation of CD8 T cells in the tumor environment.
Combining anti-CD40 agonist antibodies with exogenous IL-15 significantly boosts anti-tumor activity and promotes long-term immune memory, suggesting a promising new strategy for bladder cancer treatment that warrants further clinical investigation.
IL-15 synergizes with CD40 agonist antibodies to induce durable immunity against bladder cancer.Wong, JL., Smith, P., Angulo-Lozano, J., et al.[2023]

Citations

Antitumor activity of recombinant Bacille Calmette-Guérin secreting interleukin-15-Ag85B fusion protein against bladder cancer. [2017]
IL-15 superagonist/IL-15RαSushi-Fc fusion complex (IL-15SA/IL-15RαSu-Fc; ALT-803) markedly enhances specific subpopulations of NK and memory CD8+ T cells, and mediates potent anti-tumor activity against murine breast and colon carcinomas. [2021]
IL-15 synergizes with CD40 agonist antibodies to induce durable immunity against bladder cancer. [2023]
IL-15 synergizes with CD40 agonist antibodies to induce durable immunity against bladder cancer. [2023]
A homodimeric IL-15 superagonist F4RLI with easy preparation, improved half-life, and potent antitumor activities. [2022]
Phase I Trial Characterizing the Pharmacokinetic Profile of N-803, a Chimeric IL-15 Superagonist, in Healthy Volunteers. [2023]
Immunobiology of the IL-15/IL-15Rα complex as an antitumor and antiviral agent. [2018]
Interleukin-15 augments NK cell-mediated ADCC of alemtuzumab in patients with CD52+ T-cell malignancies. [2023]
Safety, Tolerability, and Long-Term Clinical Outcomes of an IL-15 analogue (N-803) Admixed with Bacillus Calmette-Guérin (BCG) for the Treatment of Bladder Cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Intravesical ALT-803 and BCG treatment reduces tumor burden in a carcinogen induced bladder cancer rat model; a role for cytokine production and NK cell expansion. [2022]
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