CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional study combining retrospective and prospective data from adults treated with CAR-T or bispecific antibodies at IRCCS Ospedale San Raffaele. It will collect biological samples and clinical information collected during routine care to identify biomarkers linked to treatment response and toxicity, including tumor biology, CAR-T product characteristics, and patient immune profiles. Researchers will examine how these factors relate to overall response rate and safety outcomes, aiming to understand resistance and immune escape and to inform future treatment decisions. No experimental therapies or procedures are required beyond standard clinical practice. The study will analyze both prior and future treatments, with endpoints focusing on response rates and incidence of adverse events such as cytokine release syndrome.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS San Raffaele Hospital
  Milan, Italy, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.