Immunological Profile for Patients Treated With CAR-T Cells (SI-CART)

October 7, 2021 updated by: Institut Paoli-Calmettes

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France, 13273
        • Institut Paoli-Calmettes
        • Principal Investigator:
          • Claude Lemarié, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient treated with CAR-T cells
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion
Time Frame: 1 year after T cells infusion
Serum concentration of cytokines in relation to adverse events
1 year after T cells infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAR-T cells rate from infusion to one year after CAR-T cells infusion
Time Frame: From CAR-T cells infusion to one year
Flow cytometry
From CAR-T cells infusion to one year
Number of participants with a relapse
Time Frame: From CAR-T cells infusion to one year
Relapse rate from CAR-T cells infusion to one year
From CAR-T cells infusion to one year
Number of participants with a cytokine release syndrome
Time Frame: From CAR-T cells infusion to one year
Cytokine release syndrome from CAR-T cells infusion to one year
From CAR-T cells infusion to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 5, 2021

Primary Completion (Anticipated)

October 5, 2025

Study Completion (Anticipated)

October 5, 2026

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-CART-IPC 2019-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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