Can a pneumonia shot boost CAR T-Cell success in lymphoma?
NCT ID NCT04745559
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving a pneumonia vaccine (PCV13) before and after CAR T-cell therapy helps lymphoma patients build stronger immunity. About 26 adults with certain types of B-cell lymphoma will receive the vaccine around their CAR T treatment. The goal is to see if this approach improves protection against pneumococcus bacteria.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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26 people
The number who actually took part.
- Started
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Feb 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new immune cell therapy outsmart resistant blood cancers?