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Not yet recruiting NCT05054231

Immunological Profile for Patients Treated With CAR-T Cells

No phase Interventional Hematologic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample collection.
Who it may be relevant to
Registry conditions: Hematologic Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion [Time frame: 1 year after T cells infusion]
Secondary outcome measures (3)
  • CAR-T cells rate from infusion to one year after CAR-T cells infusion [Time frame: From CAR-T cells infusion to one year]
  • Number of participants with a relapse [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Institut Paoli-Calmettes — Marseille

Identifiers

NCT: NCT05054231 · SI-CART-IPC 2019-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗