What side effects are associated with this type of intervention?

Common treatments for B-Cell Lymphoma, such as rituximab-based immunotherapy and chemotherapy regimens like cyclophosphamide, vincristine, and prednisone, often have side effects including cytopenias, infections, nausea, vomiting, and hair loss. Rituximab can cause hepatitis B reactivation and rare complications like progressive multifocal leukoencephalopathy. Cyclophosphamide may lead to hemorrhagic cystitis, bladder carcinogenesis, and interstitial pulmonary fibrosis. These treatments, while effective, require careful monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for B-Cell Lymphoma that stimulate the immune system. Rituximab, a monoclonal antibody targeting CD20 on B cells, is widely used and has shown efficacy in various B-Cell Lymphomas. Additionally, CAR T-cell therapies like axicabtagene ciloleucel and tisagenlecleucel have been approved, which involve modifying a patient's T cells to target and kill B-cell lymphoma cells. These treatments, like the PCV13 vaccine, work by enhancing the body's immune response to target specific antigens.

What other types of research exist?

Promising novel alternatives to PCV13 for B-Cell Lymphoma patients include the 15-valent pneumococcal conjugate vaccine (PCV15) and the 20-valent pneumococcal conjugate vaccine (PCV20). These vaccines cover more pneumococcal serotypes and have demonstrated strong immunogenicity and safety profiles, making them suitable options for patients with compromised immune systems.

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CAR T-cell Therapy

PCV13 + CAR T-Cell Therapy for Lymphoma

Phase 2

Recruiting

Led By Frederick Locke, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Active or uncontrolled infections

Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 90 days and 180 days post car t therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a pneumonia vaccine given before and after a special cancer treatment can help patients with difficult-to-treat blood cancers.

Who is the study for?

This trial is for adults over 18 with certain types of B-cell lymphoma who are in good health or have relapsed/refractory disease and are candidates for CD19-targeted CAR T cell therapy. They must be willing to use effective contraception if applicable, and cannot participate if they have severe allergies to vaccines, active infections, very low blood counts, recent IVIG treatment, or are pregnant.

What is being tested?

The study tests whether the pneumococcal conjugate vaccine (PCV13) given before and after CD19-targeted CAR T cell therapy can improve immune response against pneumococcus in patients with specific types of B-cell lymphoma.

What are the potential side effects?

Potential side effects from PCV13 include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite. The CAR T cell therapy may cause flu-like symptoms, difficulty breathing due to inflammation in lungs or other organs.

Eligibility Criteria

Exclusion Criteria

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

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I do not have any active or uncontrolled infections.

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I have a genetic condition that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 90 days and 180 days post car t therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 90 days and 180 days post car t therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 90 days and 180 days post car t therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Humoral Response Rate -PCV13 vaccine

Secondary study objectives

Increase in On-Specific Serotype IgG levels

Serotyping

Overall Survival

+2 more

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: TreatmentExperimental Treatment2 Interventions

Pneumococcal conjugate vaccine (PCV13) .5 ml will be administered intramuscularly three times: 7 days (range 4 to 21 days) before apheresis collection and on day +30 (range +21 to +37) and day +90 (range +75 to +115) after CAR T cell infusion.

0 / 2Eligibility 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

Common treatments for B-Cell Lymphoma include monoclonal antibodies, CAR T-cell therapy, and immune checkpoint inhibitors. Monoclonal antibodies, such as rituximab, target specific antigens on B-cells, marking them for destruction by the immune system. CAR T-cell therapy involves modifying a patient's T-cells to express chimeric antigen receptors that specifically target and kill B-cell lymphoma cells. Immune checkpoint inhibitors, like pembrolizumab, block proteins that prevent T-cells from attacking cancer cells, thereby enhancing the immune response. These treatments are crucial for B-Cell Lymphoma patients as they harness the body's immune system to specifically target and eliminate cancer cells, potentially leading to more effective and durable responses.

A Comparative and Comprehensive Review of Antibody Applications in the Treatment of Lung Disease.Monoclonal Antibodies in Cancer Therapy.Neoadjuvant treatment of locally advanced esophageal and junctional cancer: the evidence-base, current key questions and clinical trials.