Immunological Profile for Patients Treated With CAR-T Cells

Launched by INSTITUT PAOLI-CALMETTES · Sep 13, 2021

Keywords

ClinConnect Summary

This clinical trial, called the Si-CART study, is looking at how the immune system responds in patients who are receiving CAR-T cell therapy for blood cancers, known as hematologic neoplasms. During the trial, researchers will collect blood samples from participants at various times: before the CAR-T cells are given, and then on specific days after the treatment. This will help the team understand how the treatment affects the immune system over time. If a patient needs a special test of the fluid around their brain and spine, a sample will be taken then as well.

To be eligible for this study, participants need to be at least 18 years old and should be scheduled to receive CAR-T cell therapy as approved. They must also be able to provide informed consent and be part of the French social security system. Unfortunately, pregnant or breastfeeding women, those in emergency situations, or individuals unable to give consent due to legal reasons cannot participate. This study is currently not recruiting participants, so no one can join just yet, but it aims to gather important information about how CAR-T therapy affects the immune response in patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Planned injection of CAR-T cells within the scope of marketing authorization
• • Signed informed consent
• • French social security affiliation
• Exclusion Criteria:
• • Pregnant women, or women of childbearing potential (without medically acceptable contraception) or breastfeeding women.
• • Patient in emergency situation, adult under legal protection (patient placed under tutorship, curatorship, or judicial protection) or unable to give his consent
• • Impossibility to comply with trial medical follow-up for geographic, social or psychological reasons