Clinical Trial 20571

• Overview

  Study Title:

  Optimizing Cellular and Humoral Immunity to Pneumococcus by Vaccination with Pneumococcal 13-valent conjugate vaccine before and after CD19-targeted CAR T-cell Immunotherapy

  Summary:

  This is a phase II, single-institution study to investigate if pneumococcal vaccination before and after CD19-targeted CAR T cell therapy elicits cellular and humoral immunity to pneumococcus in patients with relapsed or refractory B cell lymphomas. All the participants will receive the same treatment. Immunoglobulins (IgG) against pneumococcal serotypes not included in the vaccine will be served as an internal control. Treatment includes the same dose (0.5ml) of PCV13 one time prior to apheresis followed by two times after CAR T cell therapy

  Objective:

  Primary Objective: To quantify the day +90 pneumococcal PCV13 specific serotype IgG levels following PCV13 vaccination in patients with relapsed or chemotherapy-refractory B-cell lymphomas Secondary Objectives: To evaluate increase in PCV13 specific and non-specific pneumococcal serotype IgG levels with PCV13 vaccination before and after CD19-targeted CAR T-cell therapy. To evaluate increase in cellular immunity against pneumococcus in patients with relapsed or chemotherapy-refractory B-cell lymphomas that receive PCV13 following vaccination prior to and post CD19-targeted CAR T cell therapy. To evaluate whether post CAR-T cell therapy vaccination with PCV13 leads to increased expansion of CAR T cells in vivo. To determine safety of PCV13 administered to patients with relapsed or chemotherapy-refractory B-cell lymphomas (DLBCL, PMBCL, TFL and HGBCL) before and after CD19-targeted CAR-T cell therapy. Compare and correlate responses to PCV13 vaccine, rates of severe CAR T toxicity and the efficacy of CD19-targeted CAR-T therapy (Objective response rate, 90 day PFS, 180 day PFS, and 180 day OS)

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  CD19 CAR T Cells (); PCV13 ()

• Inclusion Criteria

  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 18 and over
  • 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

  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 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 > Lymphocyte count > 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

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