Optimizing Cellular and Humoral Immunity to Pneumococcus by Vaccination with Pneumococcal 13-valent conjugate vaccine before and after CD19-targeted CAR T-cell Immunotherapy
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
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)
CD19 CAR T Cells (); PCV13 ()
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