Moffitt Cancer Center: Clinical Trial 20571

RESEARCH

Call Today

1-888-663-3488

Facebook

Twitter

Linkedin

Pinterest

Email

Clinical Trials Search

Back to Search Results

Clinical Trial 20571

Cancer Type: Immunotherapy
Study Type: Treatment
NCT#: NCT04745559

Phase: Phase II
Prinicipal Investigator: Frederick Locke

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study 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

Summary

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

Objective

Primary Objective: To quantify the day +90 pneumococcal PCV13 specific serotype IgG levels following PCV13 vaccination in patients with relapsed or chemotherapy-refractory B-cell lymphomas Secondary Objectives: To evaluate increase in PCV13 specific and non-specific pneumococcal serotype IgG levels with PCV13 vaccination before and after CD19-targeted CAR T-cell therapy. To evaluate increase in cellular immunity against pneumococcus in patients with relapsed or chemotherapy-refractory B-cell lymphomas that receive PCV13 following vaccination prior to and post CD19-targeted CAR T cell therapy. To evaluate whether post CAR-T cell therapy vaccination with PCV13 leads to increased expansion of CAR T cells in vivo. To determine safety of PCV13 administered to patients with relapsed or chemotherapy-refractory B-cell lymphomas (DLBCL, PMBCL, TFL and HGBCL) before and after CD19-targeted CAR-T cell therapy. Compare and correlate responses to PCV13 vaccine, rates of severe CAR T toxicity and the efficacy of CD19-targeted CAR-T therapy (Objective response rate, 90 day PFS, 180 day PFS, and 180 day OS)

Treatments

Therapies

Medications

CD19 CAR T Cells (); PCV13 ()

Inclusion Criteria

Inclusion Criteria:

In good health as evidenced by medical history or diagnosed with relapsed or chemotherapy-refractory DLBCL, PMLBCL, TFL and HGBCL. Patients must be under consideration for treatment with CD19-targeted CAR T cell therapy with axicabtagene ciloleucel, 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 18 and over

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

Exclusion Criteria:

Pregnant or lactating woman, as evaluated by serum testing within 72 hours of administration of the first vaccine. Only women of childbearing potential will undergo serum 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.

HIV infection confirmed by nucleic acid test (NAT), as evaluated during workup prior to CD19-targeted CAR T cell therapy

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 > Lymphocyte count > 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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.