CAR-T Cell TherapyPhase 4NCT07296120
RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients
A Phase 4 study testing Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) in people with CAR-T Cell Therapy and RSV Immunization, run by Cooper Norcross Health at 1 site in United States.
Trial summary
This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAR-T Cell Therapy, RSV Immunization, Bone Marrow Transplant - Autologous or Allogeneic
- What is being tested?
- Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Diagnosis of hematological malignancy
- Treatment with HSCT or CAR-T therapy
- Must be able to give informed consent
- Must be willing to provide blood samples after HSCT or CAR-T therapy and prior to vaccination
- Must be willing to provide blood samples at four weeks and six months post-vaccination
- Must have an insurance plan that covers the cost of recieving the RSV vaccine.
Who cannot join
- History of a severe allergic reaction to any component of the RSV vaccine
- Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
Anil K Rengan, MD, 855-632-2667, rengan-anil@cooperhealth.edu
About this study
Official title: Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients
This study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus.
The main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.
- Being tested
- Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)Biological
Patients will receive a single dose of the Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) starting at three months post-HSCT or CAR-T therapy.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Recipients | Experimental | Patients who will recieve the RSV vaccine Receives: Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold Rise in Antibody Titers and Seroconversion
The primary endpoint is the fold rise in antibody titers against the preF protein at four weeks post-vaccination compared to pre-vaccination (baseline) levels. An additional related objective is to assess whether patients are able to achieve seroconversion. The endpoint for this objective is the proportion of patients with at least a four-fold increase in neutralizing titers from the pre-vaccination baseline at four weeks post-vaccination.
Measured: From the time the patient receives the vaccine to four weeks post-vaccination.
Secondary outcomes (2)
Persistence of Humoral Immune Response
The secondary objective is to assess whether patients who achieve seroconversion at four weeks post-vaccination retain high levels of neutralizing antibodies at six months post-vaccination. The endpoint for this objective is the fold change in antibody titers against the preF protein at six months post-vaccination compared to four weeks post-vaccination.
Measured: From four weeks post-vaccination to six months post-vaccination
COVID-19 and Influenza Immunity
Although vaccination against these pathogens is not part of the study protocol, neutralizing antibody titers for influenza and COVID-19 will be obtained alongside RSV titers as part of a broader titer analysis.
Measured: From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR-T Cell TherapyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Cooper Foundation
- Responsible party
- Principal investigator, Anil Rengan, Cooper University Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296120
- Sponsor's protocol ID
- 25-114
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroconversion Following RSV Vaccination in Bone Marrow Transplant and CAR-T Patients
- ClinicalTrials.gov ID
- NCT07296120
- Acronym / sponsor ID
- 25-114
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Collaborators
- The Cooper Foundation
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Dec 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 study evaluates whether the RSV vaccine Abrysvo can produce an antibody response in patients with blood cancers who have previously received a hematopoietic stem cell transplant (HSCT) or CAR-T cell therapy. The vaccine targets the prefusion F (preF) protein of RSV, which is an important component of protective immunity against the virus.
The main goal of the study is to measure the change in antibody levels against the preF protein four weeks after vaccination compared with levels before vaccination. The study will also assess whether participants develop a meaningful immune response, defined as at least a four-fold increase in RSV neutralizing antibody levels four weeks after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine Recipients | Experimental | Biological: Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)Patients who will recieve the RSV vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Diagnosis of hematological malignancy
- Treatment with HSCT or CAR-T therapy
- Must be able to give informed consent
- Must be willing to provide blood samples after HSCT or CAR-T therapy and prior to vaccination
Key exclusion criteria (2 listed)
- History of a severe allergic reaction to any component of the RSV vaccine
- Use of intravenous immunoglobulin (IVIG) for hypogammaglobulinemia within the past six months
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 |
|---|---|---|
| Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)Patients will receive a single dose of the Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) starting at three months post-HSCT or CAR-T therapy. | Biological | Vaccine Recipients |
Primary outcome
Fold Rise in Antibody Titers and Seroconversion
Time frame: From the time the patient receives the vaccine to four weeks post-vaccination.
The primary endpoint is the fold rise in antibody titers against the preF protein at four weeks post-vaccination compared to pre-vaccination (baseline) levels. An additional related objective is to assess whether patients are able to achieve seroconversion. The endpoint for this objective is the proportion of patients with at least a four-fold increase in neutralizing titers from the pre-vaccination baseline at four weeks post-vaccination.
2 secondary outcomes
Persistence of Humoral Immune Response
Time frame: From four weeks post-vaccination to six months post-vaccination
COVID-19 and Influenza Immunity
Time frame: From the collection of baseline antibody titers to the collection of antibody titers at six months post-vaccination against RSV.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF) in people with CAR-T Cell Therapy and RSV Immunization, run by Cooper Norcross Health 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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Dec 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anil K Rengan, MD (855-632-2667, rengan-anil@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Rise in Antibody Titers and Seroconversion (time frame: From the time the patient receives the vaccine to four weeks 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 22 Dec 2025.