Immunological Profile for Patients Treated With CAR-T Cells
SI-CART
1 other identifier
interventional
500
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2021
CompletedStudy Start
First participant enrolled
October 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2026
ExpectedOctober 15, 2021
October 1, 2021
4 years
July 28, 2020
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
CAR-T cells rate from infusion to one year after CAR-T cells infusion
From CAR-T cells infusion to one year
Number of participants with a relapse
From CAR-T cells infusion to one year
Number of participants with a cytokine release syndrome
From CAR-T cells infusion to one year
Study Arms (1)
Patient treated with CAR-T cells
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Planned injection of CAR-T cells within the scope of marketing authorization
- Signed informed consent
- French social security affiliation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Paoli-Calmettes
Marseille, 13273, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
September 23, 2021
Study Start
October 5, 2021
Primary Completion
October 5, 2025
Study Completion (Estimated)
October 5, 2026
Last Updated
October 15, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share