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Immunological Profile for Patients Treated With CAR-T Cells

ConditionHematologic Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Planned injection of CAR-T cells within the scope of marketing authorization

Signed informed consent

French social security affiliation

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample collection

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patient treated with CAR-T cellsExperimental treatment 1 intervention

Trial outcomes

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

Time frame
1 year after T cells infusion

Secondary outcomes

1

CAR-T cells rate from infusion to one year after CAR-T cells infusion

Flow cytometry

Time frame
From CAR-T cells infusion to one year
2

Number of participants with a relapse

Relapse rate from CAR-T cells infusion to one year

Time frame
From CAR-T cells infusion to one year
3

Number of participants with a cytokine release syndrome

Cytokine release syndrome from CAR-T cells infusion to one year

Time frame
From CAR-T cells infusion to one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Paoli-Calmettes

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: