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Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04745559
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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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 immunity to pneumococcus.

Condition or disease Intervention/treatment Phase
Diffuse Large-Cell Lymphoma Primary Mediastinal Large B-Cell Lymphoma (PMBCL) Transformed Follicular Lymphoma (TFL) High-grade B-cell Lymphoma (HGBCL) Biological: Pneumococcal conjugate vaccine (PCV13) Biological: CD19 targeted CAR T Cell Therapy Phase 2

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Cellular and Humoral Immunity to Pneumococcus by Vaccination With Pneumococcal 13-valent Conjugate Vaccine Before and After CD19-targeted CAR T-cell Immunotherapy
Actual Study Start Date : February 18, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: Pneumococcal conjugate vaccine (PCV13)
Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine
Other Name: Prevnar 13

Biological: CD19 targeted CAR T Cell Therapy
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.


Outcome Measures
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Primary Outcome Measures :
  1. Humoral Response Rate -PCV13 vaccine [ Time Frame: 90 days post CAR T therapy ]
    Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART


Secondary Outcome Measures :
  1. Increase in PCV13 specific serotype IgG levels [ Time Frame: 90 days post CAR T therapy ]
    PCV13 specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline

  2. Increase in On-Specific Serotype IgG levels [ Time Frame: 90 days post CAR T therapy ]
    Non-specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline

  3. Response Rate of CD19-targeted CAR T therapy when combined with PCV13 vaccination [ Time Frame: 90 days post CAR T therapy ]
    Percentage of patients whose cancer shrinks or disappears after treatment

  4. Progression Free Survival [ Time Frame: at 90 days and 180 days post CAR T therapy ]
    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.

  5. Overall Survival [ Time Frame: 180 days post CAR T therapy ]
    Overall Survival (OS):The length of time from the start of treatment until death by any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) and high-grade B cell lymphoma (HGBCL). 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745559


Contacts
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Contact: Christina Lennon 813-745-3669 Christina.Lennon@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Christina Lennon    813-745-3669      
Sub-Investigator: Julio C Chavez, MD, MS         
Sub-Investigator: Marco Davila, MD, PhD         
Sub-Investigator: Michael Jain, MD, PhD         
Sub-Investigator: Farhad Khimani, MD         
Sub-Investigator: Aleksandr Lazaryan, MD, PhD, MPH         
Sub-Investigator: Dasom Lee, MD         
Sub-Investigator: Javier Pinilla, MD, PhD         
Sub-Investigator: Bijal D Shah, MD, MS         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Frederick Locke, MD Moffitt Cancer Center
More Information
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04745559    
Other Study ID Numbers: MCC-20571
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs