Immunological Profile for Patients Treated With CAR-T Cells (SI-CART)

Institut Paoli-Calmettes

Status: Not yet enrolling

Conditions: Hematologic Neoplasms

Treatments: Other: Blood sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT05054231

SI-CART-IPC 2019-006

Details and patient eligibility

About

In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.

A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Patient treated with CAR-T cells

Experimental group

Treatment:

Other: Blood sample collection