Immunological Profile for Patients Treated With CAR-T Cells

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05054231

Acronym

SI-CART

Enrollment

500

Registered

2021-09-23

Start date

2021-10-05

Completion date

2026-10-05

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms

Keywords

CAR-T cells, Immunological Profile

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

Interventions

OTHERBlood 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

Primary ContactDominique GENRE, MD

drci.up@ipc.unicancer.fr+33491223778

Backup ContactJihane PAKRADOUNI, Pharm PhD

pakradounij@ipc.unicancer.fr+33491223778

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026