This phase II trial studies the side effects of pneumococcal 13-valent conjugate vaccine and how well it works when given before and after standard of care CD19-targeted chimeric antigen receptor (CAR) T cells therapy in treating patients with B cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Pneumococcal 13-valent conjugate vaccine may help to prevention of pneumococcal disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04745559.
PRIMARY OBJECTIVES:
I. To evaluate humoral response rate to PCV13 vaccine on day +90 post CAR T cell therapy.
II. Determine the adverse event and serious adverse event rate to the PCV13 vaccine in this setting.
SECONDARY OBJECTIVES:
I. To compare the absolute PCV13 specific serotype immunoglobin G (IgG) levels on day +90 post CAR T cell therapy compared to PCV13 non-specific serotype IgG levels.
II. To trend PCV13 specific and non-specific serotype IgG levels at multiple time points.
III. To evaluate development of cellular immunity against pneumococcus in patients with PCV13 vaccination.
IV. To evaluate whether PCV13 vaccination after CAR T cell therapy leads to increased expansion of CAR T cells in vivo.
V. To compare and correlate responses to PCV13 vaccine, rates of severe CAR T toxicity and the efficacy of CD19-targeted CAR T therapy.
OUTLINE:
Patients receive pneumococcal 13-valent conjugate vaccine intramuscularly (IM) 7 days before apheresis collection for CAR T cells, and at 30 and 90 days after standard of care infusion of CAR T cells.
After completion of study treatment, patients are followed up at 90 and 180 days.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorFrederick Lundry Locke
