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NCT05054231 Clinical Trial

Immunological Profile for Patients Treated With CAR-T Cells

Hematologic Neoplasms Clinical Trial

— SI-CART  

Official title:
Immunological Profile for Patients Treated With CAR-T Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05054231
Other study ID # SI-CART-IPC 2019-006
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 5, 2021
Est. completion date October 5, 2026

Study information
Verified date October 2021
Source Institut Paoli-Calmettes
Contact Dominique GENRE, MD
Phone +33491223778
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date October 5, 2026
Est. primary completion date October 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample collection
Blood samples collection: at Day (D)-6 and D0 before CAR-T cells injection, post injection at Day (D)3, D5,D7, D9, D11, D14, D18, D 21, Month 2 and Month 12 post injection.

Locations
Country Name City State
France Institut Paoli-Calmettes Marseille

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion Serum concentration of cytokines in relation to adverse events 1 year after T cells infusion
Secondary CAR-T cells rate from infusion to one year after CAR-T cells infusion Flow cytometry From CAR-T cells infusion to one year
Secondary Number of participants with a relapse Relapse rate from CAR-T cells infusion to one year From CAR-T cells infusion to one year
Secondary Number of participants with a cytokine release syndrome Cytokine release syndrome from CAR-T cells infusion to one year From CAR-T cells infusion to one year
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