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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Pneumococcal conjugate vaccine (PCV13) .5 ml will be administered intramuscularly three times: 7 days (range 4 to 21 days) before apheresis collection and on day +30 (range +21 to +37) and day +90 (range +75 to +115) after CAR T cell infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal conjugate vaccine (PCV13) | Biological | Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Response Rate -PCV13 vaccine | Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART | 90 days post CAR T therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days post CAR T therapy |
| Increase in On-Specific Serotype IgG levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Locke, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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|
| CD19 targeted CAR T Cell Therapy | Biological | 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. |
|
Non-specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline
| 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 | 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. | 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 | 180 days post CAR T therapy |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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