Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy (NCT04745559) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy
United States26 participantsStarted 2021-02-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
What they're measuring
1
Humoral Response Rate -PCV13 vaccine
Timeframe: 90 days post CAR T therapy
Trial details
NCT IDNCT04745559
SponsorH. Lee Moffitt Cancer Center and Research Institute