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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine
This is a personalized therapeutic approach that entails removal of T cells from patient's peripheral blood, genetic modification, activation and expansion in vitro to retarget cells against CD19 protein on the surface of B cells, and infusion of the genetically engineered cells back into the patient. CD19 is a surface protein that is expressed on B cells starting from early pre-B cells to mature fully differentiated B cells. Therefore, CD19-targeted CAR T cell therapy can effectively treat refractory B cell lymphomas.
Moffitt Cancer Center
Tampa, Florida, United States
Humoral Response Rate -PCV13 vaccine
Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART
Time frame: 90 days post CAR T therapy
Increase in PCV13 specific serotype IgG levels
PCV13 specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline
Time frame: 90 days post CAR T therapy
Increase in On-Specific Serotype IgG levels
Non-specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline
Time frame: 90 days post CAR T therapy
Response Rate of CD19-targeted CAR T therapy when combined with PCV13 vaccination
Percentage of patients whose cancer shrinks or disappears after treatment
Time frame: 90 days post CAR T therapy
Progression Free Survival
Progression Free Survival (PFS) from start of treatment to death of any cause, disease progression or relapse of the date of last follow-up, whichever comes first.
Time frame: at 90 days and 180 days post CAR T therapy
Overall Survival
Overall Survival (OS):The length of time from the start of treatment until death by any cause
Time frame: 180 days post CAR T therapy
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