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NCT Number: NCT05054231

Immunological Profile for Patients Treated With CAR-T Cells

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

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique GENRE, MD

CONTACT

[email protected]

+33491223778

Jihane PAKRADOUNI, Pharm PhD

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: SI-CART

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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