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

NCT04745559 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-20571
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Mediastinal Large B-Cell Lymphoma (PMBCL); High-grade B-cell Lymphoma (HGBCL); Follicular Lymphoma; Diffuse Large-Cell Lymphoma; Transformed Follicular Lymphoma (TFL)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Response Rate of CD19-targeted CAR T therapy when combined with PCV13 vaccination

  90 days post CAR T therapy

• Progression Free Survival

  at 90 days and 180 days post CAR T therapy

• Overall Survival

  180 days post CAR T therapy

Study Arms (1)

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.

Biological: Pneumococcal conjugate vaccine (PCV13); Biological: CD19 targeted CAR T Cell Therapy

Interventions

Pneumococcal conjugate vaccine (PCV13) BIOLOGICAL

Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine

Also known as: Prevnar 13

Treatment

CD19 targeted CAR T Cell Therapy BIOLOGICAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular

Interventions

Pneumococcal Vaccines; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Frederick Locke, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: February 18, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)