Clinical trial · Interventional
Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy
Optimizing Cellular and Humoral Immunity to Pneumococcus by Vaccination With Pneumococcal 13-valent Conjugate Vaccine Before and After CD19-targeted CAR T-cell Immunotherapy
NCT04745559CI-TRIAL-00101997active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large-Cell Lymphoma | — | UNRESOLVED | — |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| High-grade B-cell Lymphoma (HGBCL) | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Primary Mediastinal Large B-Cell Lymphoma (PMBCL) | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Transformed Follicular Lymphoma (TFL) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 targeted CAR T Cell Therapy | Biological | — | UNRESOLVED |
| Pneumococcal conjugate vaccine (PCV13) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Biological: Pneumococcal conjugate vaccine (PCV13)
- Biological: CD19 targeted CAR T Cell Therapy
Primary outcomes (1)
- measure
- Humoral Response Rate -PCV13 vaccine
- timeFrame
- 90 days post CAR T therapy
- description
- Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART
Secondary outcomes (5)
- measure
- Increase in PCV13 specific serotype IgG levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.