MalignancyPhase 1/2NCT07071909
Immune Reconstitution Monitoring and Pneumococcal Vaccination in Patients Treated With CAR-T Cells
A Phase 1/2 study testing Commercial CAR-T and Investigational CAR-T in people with Malignancy and Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a prospective interventional study designed to investigate the effect of Immune Reconstitution clinic visits and pneumococcal vaccination (PCV-21) on infection risk, anti-infective prophylaxis adherence, and vaccine response in patients receiving CAR-T therapy following lymphodepletion. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Malignancy, Cancer, Hematological Malignancies
- What is being tested?
- Commercial CAR-T and Investigational CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 29 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- The subject is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Planning to receive a commercial CD19 or BCMA-directed CAR-T therapy or investigational CD30 or solid tumor CAR-T therapy as a single infusion following lymphodepletion
- Agree to provide blood samples as required by the protocol
- Willing and able to provide access to immunization history
Show all 9Show fewer
- If receiving CAR-T as part of a clinical trial, must meet all eligibility criteria for that trial
- Be willing to attend Immune Reconstitution Clinic Visits at 3, 6, 9, 12 months after CAR T-cell infusion
- Be willing to receive PCV-21 vaccination at 6 months after CAR T-cell infusion.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: Immune Reconstitution Monitoring and Pneumococcal Vaccination (PCV-21) in Patients Treated With Chimeric Antigen Receptor T-Cells
This is a prospective interventional study designed to investigate the effect of Immune Reconstitution clinic visits and pneumococcal vaccination (PCV-21) on infection risk, anti-infective prophylaxis adherence, and vaccine response in patients receiving CAR-T therapy following lymphodepletion. Fifty subjects (20 receiving commercial CAR-T for CD19 or BCMA and 30 receiving investigational CAR-T) will be enrolled. Subjects will attend Immune Reconstitution Clinic Visits at 3, 6, 9, and 12 months after CAR-T cell infusion. Subjects will be asked to provide blood samples at pre-defined intervals during CAR-T visits which will be assessed for immune composition, vaccine titers, viral titers, and immunoglobulins. Samples will be primarily used for study purposes. Leftover blood will be stored for up to five years after the last study visit and may be used for future research.
Vaccination against pneumococcal pneumonia will be offered at 6 months post-CAR-T infusion at the Immune Reconstitution Clinic Visit. Subjects will provide additional blood samples at 9- and 12 months post CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies to determine vaccine efficacy.
Read more
Long-term follow-up will continue for up to 24 months post-CAR-T infusion via medical chart abstraction.
This pilot study investigates immune reconstitution, infection risk, and vaccine response in patients receiving chimeric antigen receptor (CAR)-T cell therapy following lymphodepletion. Subjects will undergo lymphodepletion followed by CAR-T cell infusion will be included. The only additional treatment for subjects in this study is the PCV-21 pneumococcal vaccine. All CAR-T treatment procedures will adhere to the standard-of-care or the clinical trial protocol to which the subject is co-enrolled.
Subjects will provide blood samples at predefined intervals during CAR-T visits. These samples will be assessed for various laboratory studies, including blood counts, immune cell composition, viral titers, immunoglobulins, and microbiome composition.
Vaccination against pneumococcal pneumonia will be given 6 months post-CAR-T- T infusion. Subjects who opt for this vaccination will provide additional blood and blood samples at collected at 6, 9, and 12 months post-CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies. Long-term follow-up will continue for up to 24 months post-CAR-T infusion through medical chart abstraction
- Conditions
- Malignancy, Cancer, Hematological Malignancies, Lymphoma, Leukemia, Multiple Myeloma
- Being tested
- Commercial CAR-T, Investigational CAR-T
- Keywords
- Chimeric antigen receptor (CAR)-T cell therapy, cell therapy, Chimeric antigen receptor (CAR)-T, infection, vaccine response
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Lymphoma, Leukemia, Multiple Myeloma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial CAR-TBiological
Twenty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.
Investigational CAR-TBiological
Thirty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Commercial CAR-T | Experimental | Twenty subjects who are receiving commercial CAR-T for CD19 or BCMA. Receives: Biological: Commercial CAR-T |
| Investigational CAR-T | Experimental | Thirty subjects are 30 receiving investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial. Receives: Biological: Investigational CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-pneumococcal antibody concentrations
Anti-pneumococcal titers will be measured in CAR-T patients to determine proportion of patients receiving either CD19 or BCMA-directed CAR-T vs CD30 or solid tumor CAR-T who respond to PCV21 vaccination.
Measured: Baseline, 3 and 6 months post vaccination
Secondary outcomes (2)
Number of reconstitution clinic visits
Number of reconstitution clinic visits (PCP prophylaxis including sulfamethoxazole trimethoprim, pentamidine, daponse, or atovqaqune and HSV proprophylaxis including valacyclovir or acyclovir) compared to historic controls.
Measured: Up to 1 year
Difference in infection density
Difference in infection density of patients within one year post CAR-T cell therapy infusion who attend Immune Reconstitution Clinic Visits compared to historic controls.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start20 Jan 2025
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Grover, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071909
- Sponsor's protocol ID
- LCCC2337
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution Monitoring and Pneumococcal Vaccination (PCV-21) in Patients Treated With Chimeric Antigen Receptor T-Cells
- ClinicalTrials.gov ID
- NCT07071909
- Acronym / sponsor ID
- LCCC2337
- Conditions
- Malignancy, Cancer, Hematological Malignancies, Lymphoma, Leukemia, Multiple Myeloma
- Keywords
- Chimeric antigen receptor (CAR)-T cell therapy, cell therapy, Chimeric antigen receptor (CAR)-T, infection, vaccine response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective interventional study designed to investigate the effect of Immune Reconstitution clinic visits and pneumococcal vaccination (PCV-21) on infection risk, anti-infective prophylaxis adherence, and vaccine response in patients receiving CAR-T therapy following lymphodepletion. Fifty subjects (20 receiving commercial CAR-T for CD19 or BCMA and 30 receiving investigational CAR-T) will be enrolled. Subjects will attend Immune Reconstitution Clinic Visits at 3, 6, 9, and 12 months after CAR-T cell infusion. Subjects will be asked to provide blood samples at pre-defined intervals during CAR-T visits which will be assessed for immune composition, vaccine titers, viral titers, and immunoglobulins. Samples will be primarily used for study purposes. Leftover blood will be stored for up to five years after the last study visit and may be used for future research.
Vaccination against pneumococcal pneumonia will be offered at 6 months post-CAR-T infusion at the Immune Reconstitution Clinic Visit. Subjects will provide additional blood samples at 9- and 12 months post CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies to determine vaccine efficacy.
Long-term follow-up will continue for up to 24 months post-CAR-T infusion via medical chart abstraction.
This pilot study investigates immune reconstitution, infection risk, and vaccine response in patients receiving chimeric antigen receptor (CAR)-T cell therapy following lymphodepletion. Subjects will undergo lymphodepletion followed by CAR-T cell infusion will be included. The only additional treatment for subjects in this study is the PCV-21 pneumococcal vaccine. All CAR-T treatment procedures will adhere to the standard-of-care or the clinical trial protocol to which the subject is co-enrolled.
Subjects will provide blood samples at predefined intervals during CAR-T visits. These samples will be assessed for various laboratory studies, including blood counts, immune cell composition, viral titers, immunoglobulins, and microbiome composition.
Vaccination against pneumococcal pneumonia will be given 6 months post-CAR-T- T infusion. Subjects who opt for this vaccination will provide additional blood and blood samples at collected at 6, 9, and 12 months post-CAR-T infusion to assess anti-pneumococcal polysaccharide IgG antibodies. Long-term follow-up will continue for up to 24 months post-CAR-T infusion through medical chart abstraction
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial CAR-T | Experimental | Biological: Commercial CAR-TTwenty subjects who are receiving commercial CAR-T for CD19 or BCMA. |
| Investigational CAR-T | Experimental | Biological: Investigational CAR-TThirty subjects are 30 receiving investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- The subject is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Planning to receive a commercial CD19 or BCMA-directed CAR-T therapy or investigational CD30 or solid tumor CAR-T therapy as a single infusion following lymphodepletion
- Agree to provide blood samples as required by the protocol
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Commercial CAR-TTwenty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial. | Biological | Commercial CAR-T |
| Investigational CAR-TThirty subjects will receive investigational CAR-T through a University of North Carolina at Chapel Hill clinical trial. | Biological | Investigational CAR-T |
Primary outcome
Anti-pneumococcal antibody concentrations
Time frame: Baseline, 3 and 6 months post vaccination
Anti-pneumococcal titers will be measured in CAR-T patients to determine proportion of patients receiving either CD19 or BCMA-directed CAR-T vs CD30 or solid tumor CAR-T who respond to PCV21 vaccination.
2 secondary outcomes
Number of reconstitution clinic visits
Time frame: Up to 1 year
Difference in infection density
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Natalie Grover, MD principal investigator
UNC Lineberger Comprehensive 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 1/2 study testing Commercial CAR-T and Investigational CAR-T in people with Malignancy and Cancer, run by UNC Lineberger Comprehensive Cancer Center 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 9 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Anti-pneumococcal antibody concentrations (time frame: Baseline, 3 and 6 months post vaccination). 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 6 Jan 2026.