Diffuse Large-Cell LymphomaPhase 2NCT04745559
Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy
A Phase 2 study testing Pneumococcal conjugate vaccine (PCV13) and CD19 targeted CAR T Cell Therapy in people with Diffuse Large-Cell Lymphoma and Primary Mediastinal Large B-Cell Lymphoma (PMBCL), run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL)
- What is being tested?
- Pneumococcal conjugate vaccine (PCV13) and CD19 targeted CAR T Cell Therapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to Jun 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), High-grade B-cell Lymphoma (HGBCL), Follicular Lymphoma
- Being tested
- Pneumococcal conjugate vaccine (PCV13), CD19 targeted CAR T Cell Therapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal conjugate vaccine (PCV13)Biological
Also called Prevnar 13
Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine
CD19 targeted CAR T Cell TherapyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Pneumococcal conjugate vaccine (PCV13); Biological: CD19 targeted CAR T Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral Response Rate -PCV13 Vaccine
Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART
Measured: 90 days post CAR T therapy
Secondary outcomes (5)
Increase in PCV13 Specific Serotype IgG Levels
PCV13 specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline
Measured: 90 days post CAR T therapy
Increase in On-Specific Serotype IgG Levels
Non-specific serotype IgG levels on day +90 post CAR T cell therapy as an absolute and as a change from baseline
Measured: 90 days post CAR T therapy
Response Rate of CD19-targeted CAR T Therapy When Combined With PCV13 Vaccination
Percentage of patients whose cancer shrinks or disappears after treatment
Measured: 90 days post CAR T therapy
Progression Free Survival
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.
Measured: at 90 days and 180 days post CAR T therapy
Overall Survival
Overall Survival (OS):The length of time from the start of treatment until death by any cause
Measured: 180 days post CAR T therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start18 Feb 2021
- Primary completion31 Jul 2025
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick Locke, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745559
- Sponsor's protocol ID
- MCC-20571
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2021
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04745559
- Acronym / sponsor ID
- MCC-20571
- Conditions
- Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), High-grade B-cell Lymphoma (HGBCL), Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Posted 7 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Pneumococcal conjugate vaccine (PCV13), Biological: CD19 targeted CAR T Cell TherapyPneumococcal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal conjugate vaccine (PCV13)Also: Prevnar 13Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine | Biological | Treatment |
| CD19 targeted CAR T Cell TherapyThis 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. | Biological | Treatment |
Primary outcome
Humoral Response Rate -PCV13 Vaccine
Time frame: 90 days post CAR T therapy
Humoral sero-protection rate elicited by the PCV13 vaccine intervention as measured on day+90 post CART
5 secondary outcomes
Increase in PCV13 Specific Serotype IgG Levels
Time frame: 90 days post CAR T therapy
Increase in On-Specific Serotype IgG Levels
Time frame: 90 days post CAR T therapy
Response Rate of CD19-targeted CAR T Therapy When Combined With PCV13 Vaccination
Time frame: 90 days post CAR T therapy
Progression Free Survival
Time frame: at 90 days and 180 days post CAR T therapy
Overall Survival
Time frame: 180 days post CAR T therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Locke, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pneumococcal conjugate vaccine (PCV13) and CD19 targeted CAR T Cell Therapy in people with Diffuse Large-Cell Lymphoma and Primary Mediastinal Large B-Cell Lymphoma (PMBCL), run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral Response Rate -PCV13 Vaccine (time frame: 90 days post CAR T therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.