Status:
ACTIVE_NOT_RECRUITING
Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Diffuse Large-Cell Lymphoma
Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 immu...
Detailed Description
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04745559
Start Date
February 18 2021
End Date
June 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612