Back to resultsImmunological Profile for Patients Treated With CAR-T Cells (SI-CART)
Primary Purpose
Hematologic Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample collection
Sponsored by
About this trial
This is an interventional basic science trial for Hematologic Neoplasms focused on measuring CAR-T cells, Immunological Profile
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
Sites / Locations
- Institut Paoli-Calmettes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient treated with CAR-T cells
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
CAR-T cells rate from infusion to one year after CAR-T cells infusion
Flow cytometry
Number of participants with a relapse
Relapse rate from CAR-T cells infusion to one year
Number of participants with a cytokine release syndrome
Cytokine release syndrome from CAR-T cells infusion to one year
Full Information
NCT ID
NCT05054231
First Posted
July 28, 2020
Last Updated
October 7, 2021
Sponsor
Institut Paoli-Calmettes
1. Study Identification
Unique Protocol Identification Number
NCT05054231
Brief Title
Immunological Profile for Patients Treated With CAR-T Cells
Acronym
SI-CART
Official Title
Immunological Profile for Patients Treated With CAR-T Cells
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 5, 2021 (Anticipated)
Primary Completion Date
October 5, 2025 (Anticipated)
Study Completion Date
October 5, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
CAR-T cells, Immunological Profile
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient treated with CAR-T cells
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion
Description
Serum concentration of cytokines in relation to adverse events
Time Frame
1 year after T cells infusion
Secondary Outcome Measure Information:
Title
CAR-T cells rate from infusion to one year after CAR-T cells infusion
Description
Flow cytometry
Time Frame
From CAR-T cells infusion to one year
Title
Number of participants with a relapse
Description
Relapse rate from CAR-T cells infusion to one year
Time Frame
From CAR-T cells infusion to one year
Title
Number of participants with a cytokine release syndrome
Description
Cytokine release syndrome from CAR-T cells infusion to one year
Time Frame
From CAR-T cells infusion to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
+33491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jihane PAKRADOUNI, Pharm PhD
Phone
+33491223778
Email
pakradounij@ipc.unicancer.fr
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENRE Dominique, MD
Phone
33(0) 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Claude Lemarié, PharmD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunological Profile for Patients Treated With CAR-T Cells
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