CAR-T Therapy: Safety, Efficacy, and Immune-Escape Mechanisms (OSR-CAR-T)

October 28, 2026 updated by: Ciceri Fabio

Biological Observational Study for Monitoring Patients Receiving Chimeric Antigen Receptor T-cell (CAR-T) Therapies, Identifying Predictive Factors of Efficacy and Safety, and Understanding Immune-escape Mechanisms to Optimize Existing Platforms

The study is a biological, drug-related, non-interventional observational study with both retrospective and prospective components.

No experimental diagnostic procedures, investigational medicinal products, or medical devices will be used, and samples will be collected as part of routine clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a retrospective and prospective, non-interventional, biological observational study involving adult patients who receive or have received Chimeric Antigen Receptor T-cell (CAR-T) therapy or bispecific antibody therapy at IRCCS Ospedale San Raffaele.

The primary objective is to characterize patients undergoing these treatments to identify biomarkers predictive of treatment response and toxicity, support therapeutic decision-making, and identify novel therapeutic targets. The study will investigate tumor cell and tumor microenvironment signatures, biomarkers of CAR-T product fitness, and clinical variables potentially associated with treatment outcomes. These variables will include prior lines of treatment, T-cell composition before manipulation, the composition and activation status of host T-cell and myeloid cell populations, timing of cell collection, and bridging therapy.

The study will also monitor the kinetics and phenotypic and functional characteristics of CAR-T cells following infusion to investigate their association with treatment efficacy and safety. Furthermore, the study aims to improve understanding of the biological mechanisms underlying treatment resistance and immune escape, with the ultimate goal of optimizing existing therapeutic platforms.

The primary endpoints are overall response rate (ORR), defined as the proportion of patients achieving complete response (CR) or partial response (PR) following treatment ; the incidence of cytokine release syndrome (CRS); the incidence of neurotoxicity; and progression-free survival (PFS), defined as the time from the applicable treatment initiation or infusion to disease progression or death, according to the study-specific assessment criteria.

These endpoints will be evaluated in relation to biological signatures, CAR-T product characteristics, clinical variables, and post-infusion CAR-T cell kinetics and functionality.

Secondary objectives include the establishment, implementation, and maintenance of an integrated database combining clinical information with data obtained through laboratory monitoring. The study will also assess the applicability of biomarkers previously identified as predictive of response and/or toxicity in CAR-T-treated patients to patients receiving bispecific antibody therapy.

Biological samples will be collected as part of routine clinical practice or retrieved from existing biological sample collections, where available. No experimental diagnostic procedures, investigational medicinal products, or investigational medical devices will be introduced as part of the study.

Eligibility criteria

  • Eligible participants must be adults aged 18 years or older and meet at least one of the following criteria:
  • Candidates for CAR-T-cell therapy who have signed at least an initial informed consent for evaluation for this treatment at the study center.
  • Patients who have previously provided informed consent for participation in the Hematological Malignancies Biobank (Biobanca Neoplasie Ematologiche) and for whom stored biological samples are available.
  • Candidates for bispecific antibody therapy who have signed at least an initial informed consent for evaluation for this treatment at the study center.

Exclusion Criteria

- Patients participating in clinical protocols that explicitly prohibit participation in biological observational studies will be excluded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Milan, Italy, Italy, 20132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18 years or older evaluated for CAR-T-cell therapy or bispecific antibody therapy at IRCCS Ospedale San Raffaele, as well as patients with available biological samples stored in the Hematological Malignancies Biobank who have provided informed consent. Patients participating in clinical trial protocols that explicitly prohibit participation in biological observational studies will be excluded.

Description

Inclusion Criteria:

To achieve the objectives of this study, biological samples will be obtained from patients aged 18 years or older who meet at least one of the following inclusion criteria:

  • Patients eligible for CAR-T-cell therapy who have signed at least an initial informed consent for evaluation for this treatment at our center.
  • Patients who have previously signed the informed consent for the Hematological Malignancies Biobank (Biobanca Neoplasie Ematologiche) and for whom stored biological samples are available.
  • Patients eligible for bispecific antibody therapy who have signed at least an initial informed consent for evaluation for this treatment at our center.

Exclusion Criteria:

  • Participation in clinical trial protocols that explicitly prohibit participation in biological observational studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: OTHER

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients treated with CAR-T
Patients treated with bispecific antibodies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 6 months after treatment

Proportion of patients achieving a complete response (CR) or partial response (PR) following treatment.
Up to 6 months after treatment
Incidence of Cytokine Release Syndrome (CRS)
Time Frame: 1 month after treatment

Incidence of CRS and distribution of CRS severity grades following treatment, according to the applicable grading criteria.
1 month after treatment
Incidence of Neurotoxicity
Time Frame: 1 month after treatment

Incidence of ICANS and distribution of ICANS severity grades following treatment, according to the applicable grading criteria.
1 month after treatment
Progression-Free Survival (PFS)
Time Frame: 12 months after treatment initiation

Time from treatment initiation to disease progression or death from any cause.
12 months after treatment initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development and Maintenance of an Integrated Clinical and Laboratory Database
Time Frame: Through study completion, an average of 9 years

Establishment, implementation, and maintenance of an integrated database combining clinical information with data obtained from laboratory monitoring.
Through study completion, an average of 9 years
Evaluation of CAR-T-Associated Biomarkers in Patients Receiving Bispecific Antibody Therapy
Time Frame: Up to 4 years after the treatment

Assessment of the relevance of biomarkers identified as predictors of treatment response and/or toxicity in CAR-T-treated patients in patients receiving bispecific antibodies directed against the same therapeutic targets.
Up to 4 years after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ciceri Fabio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSR-CAR-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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