N-803 for Non-Hodgkin's Lymphoma

(CARMEN-803 Trial)

Overseen By Catherine Cromar

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Utah

Must not be taking: Investigational agents

Disqualifiers: Autoimmune disease, Uncontrolled illness, HIV, others

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

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called N-803 to determine its safety for people with B-cell non-Hodgkin's lymphoma who have already received CAR T-cell therapy. Participants will receive N-803 through a simple injection every 21 days, up to six times. This trial suits those who have shown some improvement with CAR T-cell therapy and are in stable condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial requires a washout period (time without taking certain medications) for any prohibited medications, lasting at least five half-lives of the drug or as clinically indicated. It's best to discuss your current medications with the trial team to see if any are prohibited.

Is there any evidence suggesting that N-803 is likely to be safe for humans?

Previous studies have shown promising safety results for N-803. Research indicates that this treatment is generally well-tolerated. For example, when combined with other treatments, N-803 proved safe and led to positive outcomes. Participants did not experience severe side effects, and their immune cells remained active even weeks after treatment. This suggests that N-803 is likely safe for humans. Although this trial is still in its early stages, existing data provides a good indication of its tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

N-803 is unique because it enhances the body's natural killer (NK) cells to fight Non-Hodgkin's Lymphoma. Unlike conventional treatments like chemotherapy and antibody therapies, which primarily target cancer cells directly, N-803 boosts the immune system's ability to attack these cells. Researchers are excited about N-803's potential for fewer side effects and its subcutaneous administration, which can be more convenient and less invasive compared to intravenous options. This new approach could offer a promising alternative for patients looking for treatments beyond the current standards.

What evidence suggests that N-803 might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that N-803, a drug that boosts the immune system, may enhance the body's natural and learned defenses against lymphoma. Early studies found it safe and well-tolerated, even in patients unresponsive to rituximab, a common lymphoma treatment. Some patients experienced long-lasting positive effects from the treatment. These findings suggest that N-803, which participants in this trial will receive, could benefit people with non-Hodgkin's lymphoma, especially those who have undergone CAR T-cell therapy. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with B-cell non-Hodgkin lymphoma who have already had CAR T-cell therapy. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.

Inclusion Criteria

My blood, liver, and kidney functions are all within normal ranges.

I am 18 years old or older.

I am not pregnant or I am post-menopausal.

Exclusion Criteria

I have previously received N-803, IL-2, or IL-15 based therapy.

I am not taking any medications that are not allowed in the study.

Receiving other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive N-803 subcutaneously on day 1 of each 21-day cycle for up to 6 cycles

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• N-803

Trial Overview

The study is testing the safety and tolerability of a drug called N-803 as maintenance therapy in patients who've received CAR T-cell therapy for B-cell non-Hodgkin lymphoma.

How Is the Trial Designed?

Group I: N-803 Experimental Treatment 1 Intervention

Participants receive N-803 subcutaneously (SubQ) administered on day 1 of each 21-day cycle for up to 6 cycles.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

ImmunityBio, Inc.

Industry 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/PMC8197753/

Phase 1 trial of N-803, an IL-15 receptor agonist, with ...

These findings suggest that N-803 may simultaneously enhance innate and adaptive immune responses to lymphoma. Future studies correlating the magnitude of ...

2.

immunitybio.com

immunitybio.com/non-hodgkin-lymphoma/

Non-Hodgkin Lymphoma

Then, because one of the goals of the trial is compare treatment with or without N-803, half of the patients will receive another 4 weeks of treatment with CD19 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05618925

NCT05618925 | Study for Subjects With Relapsed/ ...

This is a phase 1, first-in-human (FIH), open-label study to evaluate the safety of CD19 t-haNK as a single agent and the safety and preliminary efficacy of ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10858928/

Cost-effectiveness analysis alongside the inter-B-NHL ritux ...

The randomized controlled trial Inter-B-NHL ritux 2010 showed overall survival (OS) benefit and event-free survival (EFS) benefit with the addition of ...

5.

aacrjournals.org

aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-20-4575/672437/p/Phase-I-Trial-of-N-803-an-IL15-Receptor-Agonist

Phase I Trial of N-803, an IL15 Receptor Agonist, with ...

Results: This immunotherapy combination was safe and well tolerated and resulted in durable clinical responses including in rituximab-refractory patients.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33832946/

Phase I Trial of N-803, an IL15 Receptor Agonist ... - PubMed

N-803 combines with mAbs to enhance tumor targeting in patients, and warrants further investigation in combination with immunotherapies.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07125872

Open Label, Phase 2 Study of CD19t-haNK and N-803 in ...

Participants will receive treatment for a maximum of 12 cycles( 36 weeks) or until they have PD, unacceptable toxicity, withdrawal consent, ...

8.

aacrjournals.org

aacrjournals.org/clincancerres/article/27/12/3339/671463/Phase-I-Trial-of-N-803-an-IL15-Receptor-Agonist

Phase I Trial of N-803, an IL15 Receptor Agonist, with ...

Our findings add to prior work on N-803 demonstrating here that NK and CD8+ T-cell total counts remain elevated 8 weeks after N-803 treatment, suggesting a ...

9.

figshare.com

figshare.com/collections/Data_from_Phase_I_Trial_of_N-803_an_IL15_Receptor_Agonist_with_Rituximab_in_Patients_with_Indolent_Non-Hodgkin_Lymphoma/6529959

Data from Phase I Trial of N-803, an IL15 Receptor Agonist ...

This immunotherapy combination was safe and well tolerated and resulted in durable clinical responses including in rituximab-refractory patients.