INfections in Patients Treated With CAR-T (IN-CART)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: B-Cell Non-Hodgkin Lymphoma; Refractory Multiple Myeloma; Relapsed Multiple Myeloma; Bloodstream Infections; CAR-T Cell Therapy

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 Type: Observational
• Enrollment (Estimated): 290

Contacts and Locations

• Study Contact: Name: Maddalena Giannella, MD, PhD; Phone Number: +39 051 2143199; Email: maddalena.giannella@unibo.it
• Study Contact Backup: Name: Zeno Adrien Igor Pasquini, MD; Phone Number: +39 051 214 3752; Email: zeno.pasquini@aosp.bo.it

Study Locations

• Italy
  • Italy
    • Bologna, Italy, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Maddalena Giannella, MD, PhD; Phone Number: +39 051 2143199; Email: maddalena.giannella@unibo.it
      • Contact: Zeno Adrien Igor Pasquini, MD; Phone Number: +39 051 214 3752; Email: zeno.pasquini@aosp.bo.it
      • Principal Investigator: Zeno Adrien Igor Pasquini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 12 months after CAR-T infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Up to 12 months after enrollment (at the first febrile episode)

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Zeno Adrien Igor Pasquini, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; CAR-T; CRS; Bloodstream Infection; Cytokine Release Syndrome; CAR-T Cell Therapy; Infectious Complications; B-cell Non-Hodgkin Lymphoma; CAR-T Cell Infusion; ddPCR blood test
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Immune System Diseases; Infections; Neoplasms by Histologic Type; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Shock; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Cytokine Release Syndrome; Lymphoma, B-Cell; Sepsis; Multiple Myeloma
• Other Study ID Numbers: IN-CART; RC-2026-2802107 (Other Grant/Funding Number: Italian Ministry of Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No