Study on Improving Immunity with PCV13 Vaccine Before and After CAR-T Therapy

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04745559

Provider View

This clinical trial is exploring whether the PCV13 vaccine, given before and after CAR-T cell therapy, can enhance the immune response against pneumococcus in patients with certain types of B cell lymphomas.

Patient Parameters

Program Overview

The study aims to find out if receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before and after CAR-T cell therapy can improve the body's immune response to pneumococcus in patients with relapsed or hard-to-treat B cell lymphomas. All participants will receive the same treatment, which includes the PCV13 vaccine given once before and twice after the CAR-T cell therapy.

Description

This is a phase II study conducted at a single institution to see if the PCV13 vaccine can boost immunity against pneumococcus in patients undergoing CD19-targeted CAR-T cell therapy for certain B cell lymphomas. Participants will receive the PCV13 vaccine once before apheresis (a procedure to collect blood cells) and twice after the CAR-T cell therapy. The study will measure the immune response to pneumococcus, including types not covered by the vaccine, to see if the vaccination strategy is effective.

Eligibility Criteria

Inclusion Criteria

  • Be in good health or have relapsed or hard-to-treat B cell lymphomas like diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, transformed follicular lymphoma, high-grade B cell lymphoma, or follicular lymphoma.
  • Be considered for CD19-targeted CAR-T cell therapy.
  • Have a planned date for apheresis for CAR-T cell therapy.
  • Be 18 years or older.
  • Agree to follow all study procedures and be available for the study duration.
  • Women of childbearing potential must use effective birth control for at least one month before the study and during participation.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Have common variable immunodeficiency or other inherited immune system disorders.
  • Have a history of severe allergic reactions to components of the PCV13 vaccine or similar vaccines.
  • Be part of another trial that involves starting maintenance chemotherapy within three months of CAR-T cell therapy.
  • Have significant psychiatric illness affecting study compliance.
  • Have active or uncontrolled infections.
  • Have very low platelet or lymphocyte counts.
  • Have received intravenous immunoglobulin (IVIG) or the PCV13 vaccine within one month before apheresis for CAR-T cell therapy.

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