What is the mechanism of action of this treatment?

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include immunotherapies that harness the body's immune system to target and destroy cancer cells. CD19 t-haNK therapy uses engineered Natural Killer (NK) cells to target CD19, a protein on B-cell malignancies, directly killing the cancer cells. N-803, an IL-15 superagonist, enhances NK and T cell activity, boosting the immune response against cancer. These therapies are significant for NHL patients as they offer targeted treatment options that can be more effective and less toxic than traditional chemotherapy, potentially improving patient outcomes and quality of life.

What side effects are associated with this type of intervention?

Common side effects of treatments for Non-Hodgkin's Lymphoma, particularly those involving engineered NK cells and IL-15 superagonists, include cytokine release syndrome (CRS) with symptoms like fever, fatigue, and muscle pain, as well as immune-related adverse events (irAEs) such as colitis, pneumonitis, and endocrinopathies. Infusion-related reactions, including chills, fever, and low blood pressure, are also common. Close monitoring and management of these side effects are essential for patient safety.

What prior FDA approvals exist?

The FDA has approved several therapies for the treatment of Non-Hodgkin's Lymphoma that involve targeting CD19 or enhancing immune cell activity. Notably, CAR-T cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) target CD19 on B cells and have shown significant efficacy in relapsed or refractory NHL. Additionally, monoclonal antibodies like rituximab (Rituxan) target CD20, another B cell marker, and are commonly used in combination with chemotherapy. While not directly targeting CD19, these therapies represent significant advancements in leveraging the immune system to combat NHL.

What other types of research exist?

Promising novel alternatives for Non-Hodgkin's Lymphoma patients include CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory NHL. Additionally, bispecific T-cell engagers (BiTEs) like blinatumomab, which directs T-cells to target CD19-expressing cells, and novel monoclonal antibodies such as polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, are also promising options. These therapies offer new mechanisms of action and have demonstrated positive outcomes in clinical settings.

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CAR T-cell Therapy

Combination Therapy for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Research Sponsored by ImmunityBio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days after each cell infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with Non-Hodgkin Lymphoma who haven't responded to other treatments. It uses special immune cells, a cancer drug, and an immune booster to target and kill cancer cells.

Who is the study for?

Adults with certain types of B-cell Non-Hodgkin Lymphoma that have worsened after at least two chemotherapy treatments. Participants must have previously received anti-CD20 antibody therapy, be able to get a central line for drug infusions, and commit to follow-up visits. They should not be pregnant or breastfeeding and agree to use effective contraception.

What is being tested?

The trial is testing CD19t-haNK alone and combined with N803 (an IL-15 superagonist) and Rituximab in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma. It's an open-label, Phase 1 study where participants are randomly assigned to one of two groups.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, blood cell count changes which can affect immunity and clotting, as well as possible digestive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days after each cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days after each cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days after each cell infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measures

Secondary study objectives

measures

Other study objectives

Duration of response (DoR) in accordance with LYRIC

Overall survival (OS) after infusion

Progression-free survival (PFS) after infusion in accordance with LYRIC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment5 Interventions

Subjects in both cohorts will initially receive lymphodepleting chemotherapy followed by a single 4-week cycle of the CD19 t-haNK single-agent regimen. Following a 1-week rest period, subjects will then receive lymphodepleting chemotherapy followed by a single 4-week cycle of CD19 t-haNK in combination with rituximab (cohort A) or in combination with rituximab and N-803 (cohort B).

Group II: Arm AExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

N803

2020

Completed Phase 2

~30

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include immunotherapies that harness the body's immune system to target and destroy cancer cells. CD19 t-haNK therapy uses engineered Natural Killer (NK) cells to target CD19, a protein on B-cell malignancies, directly killing the cancer cells. N-803, an IL-15 superagonist, enhances NK and T cell activity, boosting the immune response against cancer. These therapies are significant for NHL patients as they offer targeted treatment options that can be more effective and less toxic than traditional chemotherapy, potentially improving patient outcomes and quality of life.