Relapsed Multiple MyelomaIN-CARTNCT07713511
INfections in Patients Treated With CAR-T
An observational study of Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, B-Cell Non-Hodgkin Lymphoma
- How many people
- 290 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2026to 30 Apr 2029
- Phase
- Observational
- 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
Study population: Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods
Who may be able to join
- Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL)
- Receipt of CAR-T infusion at IRCCS AOUBo
- Age ≥18 years at the time of CAR-T infusion
- Signed informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Zeno Adrien Igor Pasquini, MD, +39 051 214 3752, zeno.pasquini@aosp.bo.it
Maddalena Giannella, MD, PhD, +39 051 2143199, maddalena.giannella@unibo.it
About this study
Official title: INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.
Read the detailed description
This is a single-center observational study involving adult patients with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who received/will receive CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to evaluate how often infections occur during the first 12 months after CAR-T infusion and to describe their main characteristics and risk factors. Both patients treated since 2019 (retrospective cohort) and newly enrolled patients during the year following study approval (prospective cohort) will be included, with one year of follow-up after infusion.
The study will investigate factors associated with infection risk, the impact of preventive and therapeutic anti-infective strategies, the distinction between infection-related fever and cytokine release syndrome (CRS), post-discharge infections, and immune recovery after CAR-T therapy. In the prospective cohort, patients who develop their first fever episode after CAR-T infusion will also undergo a validated rapid molecular blood test (PilotGene ddPCR Blood System), alongside standard blood cultures, to improve the speed of bloodstream infection diagnosis. The test is already used in clinical practice and will serve as a complementary diagnostic tool without changing standard patient management. Approximately 290 patients are expected to be included, most of whom with lymphoma.
- Conditions
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, B-Cell Non-Hodgkin Lymphoma, Bloodstream Infections, CAR-T Cell Therapy
- Keywords
- Multiple Myeloma, B-cell Non-Hodgkin Lymphoma, CAR-T Cell Therapy, CAR-T Cell Infusion, Bloodstream Infection, Infectious Complications, CAR-T, ddPCR blood test, Cytokine Release Syndrome, CRS
- Medical subject headings
- Multiple Myeloma, Lymphoma, B-Cell, Sepsis, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients (≥18 years old) undergoing CAR-T cell therapy at IRCCS AOUBo | Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
Measured: Within 12 months after CAR-T infusion
Secondary outcomes (5)
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
Adjusted odds ratios with 95% confidence intervals for the association between predefined pre-infusion and post-infusion variables and the occurrence of at least one infectious complication after CAR-T infusion.
Measured: Within 12 months after CAR-T infusion
Classification of the first febrile episode within 30 days after CAR-T infusion.
Classification of each participant's first febrile episode as no fever, infection-related fever, indeterminate fever, or cytokine release syndrome (CRS)-related fever.
Measured: Within the first 30 days after CAR-T infusion
Participants with microbiologically documented infection at the first febrile episode.
Number (or percentage) of participants with a microbiologically documented infection identified at the time of the first febrile episode.
Measured: Within the first 30 days after CAR-T infusion.
Post-Discharge Infectious Complications.
Percentage of participants with at least one infectious complication occurring after hospital discharge.
Measured: From hospital discharge up to 12 months after CAR-T infusion.
Diagnostic Yield of the Pilot Gene ddPCR Blood Test.
Percentage of first febrile episodes with at least one pathogen and/or antimicrobial resistance marker detected by the Pilot Gene droplet digital polymerase chain reaction blood test.
Measured: Up to 12 months after enrollment (at the first febrile episode)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeno Adrien Igor Pasquini, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713511
- Sponsor's protocol ID
- IN-CART
- Other IDs
- RC-2026-2802107
- Acronym
- IN-CART
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INfections in Patients Treated With CAR-T: Analysis of Incidence, Risk Factors, and Management Strategies
- ClinicalTrials.gov ID
- NCT07713511
- Acronym / sponsor ID
- IN-CART / IN-CART
- Conditions
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, B-Cell Non-Hodgkin Lymphoma, Bloodstream Infections, CAR-T Cell Therapy
- Keywords
- Multiple Myeloma, B-cell Non-Hodgkin Lymphoma, CAR-T Cell Therapy, CAR-T Cell Infusion, Bloodstream Infection, Infectious Complications, CAR-T, ddPCR blood test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 20 Jul 2026 (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 includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.
Detailed description
This is a single-center observational study involving adult patients with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who received/will receive CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to evaluate how often infections occur during the first 12 months after CAR-T infusion and to describe their main characteristics and risk factors. Both patients treated since 2019 (retrospective cohort) and newly enrolled patients during the year following study approval (prospective cohort) will be included, with one year of follow-up after infusion.
The study will investigate factors associated with infection risk, the impact of preventive and therapeutic anti-infective strategies, the distinction between infection-related fever and cytokine release syndrome (CRS), post-discharge infections, and immune recovery after CAR-T therapy. In the prospective cohort, patients who develop their first fever episode after CAR-T infusion will also undergo a validated rapid molecular blood test (PilotGene ddPCR Blood System), alongside standard blood cultures, to improve the speed of bloodstream infection diagnosis. The test is already used in clinical practice and will serve as a complementary diagnostic tool without changing standard patient management. Approximately 290 patients are expected to be included, most of whom with lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients (≥18 years old) undergoing CAR-T cell therapy at IRCCS AOUBo | – | –Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods
Key inclusion criteria (4 listed)
- Diagnosis of relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL)
- Receipt of CAR-T infusion at IRCCS AOUBo
- Age ≥18 years at the time of CAR-T infusion
- Signed informed consent
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.
Primary outcome
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
Time frame: Within 12 months after CAR-T infusion
Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
5 secondary outcomes
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
Time frame: Within 12 months after CAR-T infusion
Classification of the first febrile episode within 30 days after CAR-T infusion.
Time frame: Within the first 30 days after CAR-T infusion
Participants with microbiologically documented infection at the first febrile episode.
Time frame: Within the first 30 days after CAR-T infusion.
Post-Discharge Infectious Complications.
Time frame: From hospital discharge up to 12 months after CAR-T infusion.
Diagnostic Yield of the Pilot Gene ddPCR Blood Test.
Time frame: Up to 12 months after enrollment (at the first febrile episode)
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 20 Jul 2026.
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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.
Zeno Adrien Igor Pasquini principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 4 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: opening soon, as of the sponsor's last update on 20 Jul 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 Italy. 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.
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 Zeno Adrien Igor Pasquini, MD (+39 051 214 3752, zeno.pasquini@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion. (time frame: Within 12 months after CAR-T infusion). 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 20 Jul 2026.