Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy

Running, not enrolling · Phase 2

Conditions studied: Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), High-grade B-cell Lymphoma (HGBCL), Follicular Lymphoma

In brief

The purpose of the study is to evaluate whether receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before and after CD19-targeted CAR T cell therapy will optimize cellular and humoral immunity to pneumococcus.

Key facts

Study ID

NCT04745559

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

26

Starts

2021-02-18

Expected to finish

2027-06-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In good health as evidenced by medical history or diagnosed with relapsed or chemotherapy-refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMLBCL), transformed follicular lymphoma (TFL) high-grade B cell lymphoma (HGBCL) or Follicular Lymphoma. Patients must be under consideration for treatment with any CD19-targeted CAR T cell therapy, per institutional standards. Patients undergoing active vital organ testing with a planned apheresis date for CAR T cell therapy may be considered eligible.
• Signed informed consent form in accordance with institutional and federal law policies
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age over 18
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

You may not qualify if…

• Pregnant or lactating woman, as evaluated by serum testing within 2 weeks of administration of the first vaccine. Only women of childbearing potential will undergo serum/urine pregnancy testing. A woman will be considered of childbearing potential unless she is status-post hysterectomy or tubal ligation or without menstrual periods in the preceding 12 months.
• Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
• History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 valent (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
• Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of CD19-targeted CAR T cell therapy
• Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
• Active or uncontrolled infections
• Platelet count <10,000 cells/microliter
• Lymphocyte count <200 cells/microliter
• Intervenous immunoglobulin (IVIG) administration within one month of planned apheresis for collection for CD19-targeted CAR T cell manufacture
• History of PCV13 administration within one month of planned apheresis for collection for CD19-targeted CAR T cell manufacture

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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