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

February 21, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute

Optimizing Cellular and Humoral Immunity to Pneumococcus by Vaccination With Pneumococcal 13-valent Conjugate Vaccine Before and After CD19-targeted CAR T-cell Immunotherapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Sub-Investigator:
          • Marco Davila, MD, PhD
        • Sub-Investigator:
          • Michael Jain, MD, PhD
        • Sub-Investigator:
          • Farhad Khimani, MD
        • Sub-Investigator:
          • Javier Pinilla, MD, PhD
        • Sub-Investigator:
          • Julio C Chavez, MD, MS
        • Sub-Investigator:
          • Aleksandr Lazaryan, MD, PhD, MPH
        • Sub-Investigator:
          • Dasom Lee, MD
        • Sub-Investigator:
          • Bijal D Shah, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days post CAR T therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days post CAR T therapy
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
90 days post CAR T therapy
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
90 days post CAR T therapy
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.
at 90 days and 180 days post CAR T therapy
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
180 days post CAR T therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Frederick Locke, MD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20571

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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