Immunological Profile for Patients Treated With CAR-T Cells

Not Applicable

Not yet recruiting

• Conditions: Hematologic Neoplasms

• Registration Number: NCT05054231
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-23
• Status Verified: 2021-10
• Study Start: 2021-10-05
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-15
• Primary Completion: 2025-10-05
• Study Completion: 2026-10-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion	1 year after T cells infusion	Serum concentration of cytokines in relation to adverse events

Secondary Outcome Measures

Name	Time	Method
Number of participants with a cytokine release syndrome	From CAR-T cells infusion to one year	Cytokine release syndrome from CAR-T cells infusion to one year
CAR-T cells rate from infusion to one year after CAR-T cells infusion	From CAR-T cells infusion to one year	Flow cytometry
Number of participants with a relapse	From CAR-T cells infusion to one year	Relapse rate from CAR-T cells infusion to one year

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France