Optimizing Cellular and Humoral Immunity to Pneumococcus by Vaccination With Pneumococcal 13-valent Conjugate Vaccine Before and After CD19-targeted CAR T-cell Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Humoral Response Rate -PCV13 vaccine
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment
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.
干预措施: Pneumococcal conjugate vaccine (PCV13) (Biological)
Treatment
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.
干预措施: CD19 targeted CAR T Cell Therapy (Biological)
结局指标
主要结局
Humoral Response Rate -PCV13 vaccine
时间窗: 90 days post CAR T therapy
Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART
次要结局
- Response Rate of CD19-targeted CAR T therapy when combined with PCV13 vaccination(90 days post CAR T therapy)
- Increase in PCV13 specific serotype IgG levels(90 days post CAR T therapy)
- Increase in On-Specific Serotype IgG levels(90 days post CAR T therapy)
- Overall Survival(180 days post CAR T therapy)
- Progression Free Survival(at 90 days and 180 days post CAR T therapy)