What is the mechanism of action of this treatment?

CAR-T cell therapy is a promising treatment for Marginal Zone Lymphoma (MZL) that involves modifying a patient's T-cells to express chimeric antigen receptors (CARs) targeting cancerous B-cells. This approach is significant for MZL patients as it directly targets and kills the malignant B-cells, potentially leading to substantial remissions. Other common treatments for MZL include monoclonal antibodies, which target specific proteins on cancer cells, and chemotherapy, which kills rapidly dividing cells. These treatments are crucial as they offer different mechanisms to control or eliminate the cancer, providing multiple therapeutic options for patients.

What side effects are associated with this type of intervention?

Common treatments for Marginal Zone Lymphoma (MZL) include immunotherapy, chemotherapy, and targeted therapies. CAR-T cell therapy, a newer treatment being studied, involves genetically modifying a patient's T cells to target and kill cancerous B cells. Known side effects of CAR-T cell therapy include cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and difficulty breathing. Other serious side effects include neurotoxicity, which can lead to confusion, seizures, and severe headaches, as well as an increased risk of infections due to the immunosuppressive nature of the treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for CAR-T cell therapies targeting Marginal Zone Lymphoma (MZL). However, treatments for MZL often include immunotherapies that target B-cells, such as rituximab, an anti-CD20 monoclonal antibody. Other FDA-approved therapies for MZL include ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, and zanubrutinib, another BTK inhibitor. These treatments work by targeting pathways critical for the survival of B-cells, similar to the mechanism of CAR-T cell therapies.

What other types of research exist?

Promising novel alternatives to CAR-T cell therapy for Marginal Zone Lymphoma patients in 2024 include: 1) BTK inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib, which target B-cell receptor signaling pathways. 2) Monoclonal antibodies like obinutuzumab and rituximab, which target CD20 on B-cells. 3) Bispecific T-cell engagers (BiTEs) such as teclistamab, which redirect T-cells to target B-cells. 4) Immune checkpoint inhibitors like pembrolizumab and nivolumab, which enhance the immune system's ability to fight cancer. These therapies have shown efficacy in B-cell malignancies and may offer effective treatment options for MZL patients.

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CAR T-cell Therapy

CAR T-Cell Therapy for Lymphoma and Leukemia

Phase 2

Recruiting

Led By John Lister, MD

Research Sponsored by John Lister

Eligibility Criteria Checklist

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

Must have

Subjects with CD19+ B-cell lymphoma or B-Cell Acute Lymphoblastic Leukemia (B-ALL) with no currently available curative treatment option and a limited prognosis (<2-year projected survival)

Subjects must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate

Must not have

Active untreated CNS (central nervous system) leukemia or lymphoma

Concurrent second malignancy requiring active therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses CAR T-cell therapy, which involves modifying a patient's immune cells to fight cancer. It targets patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia who may not respond to standard treatments. The treatment works by collecting, modifying, and reinfusing the patient's own immune cells to attack cancer cells. CAR T-cell therapy has shown remarkable success in treating B-cell malignancies, including B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma.

Who is the study for?

Adults aged 18-79 with certain types of B-cell lymphoma or acute lymphoblastic leukemia that lack curative treatment options and have a life expectancy under two years. They must not be eligible for commercial CAR T-cell therapy, have measurable disease, and be able to understand the trial. Pregnant women, those unable to consent, or patients with active central nervous system cancer are excluded.

What is being tested?

The trial is testing locally manufactured CAR T-cells in treating various forms of B-cell lymphoma and acute lymphoblastic leukemia. It aims to show this method can safely create and administer these cells to help manage these cancers when other treatments aren't available.

What are the potential side effects?

Potential side effects may include immune reactions leading to symptoms like fever and fatigue (cytokine release syndrome), neurological events such as confusion or seizures, blood cell count changes increasing infection risk, allergic reactions during infusion, and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have B-cell cancer with no cure and am expected to live less than 2 years.

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I understand the risks and can consent to join the trial on my own.

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I am between 18 and 79 years old.

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My cancer cells have shown CD19 presence at some point.

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I have a specific type of lymphoma or leukemia and previous treatments haven't worked.

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I cannot receive the standard CD19-CAR T-cell therapy.

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I don't need extra oxygen and I don't have trouble breathing when resting.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have leukemia or lymphoma in my brain that hasn't been treated.

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I am currently being treated for another type of cancer.

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I have hepatitis C with ongoing viral replication.

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I currently have an active infection.

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I have had a heart attack in the last 6 months or have heart issues that are not under control.

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I received targeted radiation therapy within the last 14 days.

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I have HIV with active viral replication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety of administration

Successful local CAR T-cell manufacturing

Secondary study objectives

CAR T-cell kinetics

Response to therapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

CAR -T-cell collection, infusion

0 / 15Eligibility criteria met

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

CAR-T cell therapy is a promising treatment for Marginal Zone Lymphoma (MZL) that involves modifying a patient's T-cells to express chimeric antigen receptors (CARs) targeting cancerous B-cells. This approach is significant for MZL patients as it directly targets and kills the malignant B-cells, potentially leading to substantial remissions. Other common treatments for MZL include monoclonal antibodies, which target specific proteins on cancer cells, and chemotherapy, which kills rapidly dividing cells. These treatments are crucial as they offer different mechanisms to control or eliminate the cancer, providing multiple therapeutic options for patients.