Description:
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.
Title
- Brief Title: Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy
- 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
Clinical Trial IDs
- ORG STUDY ID:
MCC-20571
- NCT ID:
NCT04745559
Conditions
- Diffuse Large-Cell Lymphoma
- Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- Transformed Follicular Lymphoma (TFL)
- High-grade B-cell Lymphoma (HGBCL)
Interventions
Drug | Synonyms | Arms |
---|
Pneumococcal conjugate vaccine (PCV13) | Prevnar 13 | Treatment |
CD19 targeted CAR T Cell Therapy | | Treatment |
Purpose
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.
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
Trial Arms
Name | Type | Description | Interventions |
---|
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. | - Pneumococcal conjugate vaccine (PCV13)
- CD19 targeted CAR T Cell Therapy
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Humoral Response Rate -PCV13 vaccine |
Time Frame: | 90 days post CAR T therapy |
Safety Issue: | |
Description: | Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART |
Secondary Outcome Measures
Measure: | Increase in PCV13 specific serotype IgG levels |
Time Frame: | 90 days post CAR T therapy |
Safety Issue: | |
Description: | PCV13 specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline |
Measure: | Increase in On-Specific Serotype IgG levels |
Time Frame: | 90 days post CAR T therapy |
Safety Issue: | |
Description: | Non-specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline |
Measure: | Response Rate of CD19-targeted CAR T therapy when combined with PCV13 vaccination |
Time Frame: | 90 days post CAR T therapy |
Safety Issue: | |
Description: | Percentage of patients whose cancer shrinks or disappears after treatment |
Measure: | Progression Free Survival |
Time Frame: | at 90 days and 180 days post CAR T therapy |
Safety Issue: | |
Description: | 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. |
Measure: | Overall Survival |
Time Frame: | 180 days post CAR T therapy |
Safety Issue: | |
Description: | Overall Survival (OS):The length of time from the start of treatment until death by any cause |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Last Updated
July 14, 2021