Clinical trial · Interventional
Immunological Profile for Patients Treated With CAR-T Cells
NCT05054231CI-TRIAL-00054469SI-CARTnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient treated with CAR-T cells
- interventionNames
- Other: Blood sample collection
Primary outcomes (1)
- measure
- Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion
- timeFrame
- 1 year after T cells infusion
- description
- Serum concentration of cytokines in relation to adverse events
Secondary outcomes (3)
- measure
- CAR-T cells rate from infusion to one year after CAR-T cells infusion
- timeFrame
- From CAR-T cells infusion to one year
- description
- Flow cytometry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.