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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms

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