CELL INTELLIGENCE · 肿瘤细胞治疗研究

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 over 18
* 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:

* 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 \<10,000 cells/microliter
* Lymphocyte count \<200 cells/microliter
* 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

主要终点：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
次要终点：Increase in PCV13 specific serotype IgG levels；Increase in On-Specific Serotype IgG levels；Response Rate of CD19-targeted CAR T therapy when combined with PCV13 vaccination；Progression Free Survival；Overall Survival

• 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.

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.