Hematologic NeoplasmsSI-CARTNCT05054231
Immunological Profile for Patients Treated With CAR-T Cells
A study testing Blood sample collection in people with Hematologic Neoplasms, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Blood sample collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2021to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Planned injection of CAR-T cells within the scope of marketing authorization
- Signed informed consent
- French social security affiliation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Institut Paoli-Calmettes
Marseille, 13273
GENRE Dominique, MD, 33(0) 4 91 22 37 78, drci.up@ipc.unicancer.fr
Claude Lemarié, PharmD
About this study
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
- Hematologic Neoplasms
- Being tested
- Blood sample collection
- Keywords
- CAR-T cells, Immunological Profile
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
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 group | Role | What they receive |
|---|---|---|
| Patient treated with CAR-T cells | Experimental | Not described Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after T cells infusion
Secondary outcomes (3)
CAR-T cells rate from infusion to one year after CAR-T cells infusion
Flow cytometry
Measured: From CAR-T cells infusion to one year
Number of participants with a relapse
Relapse rate from CAR-T cells infusion to one year
Measured: From CAR-T cells infusion to one year
Number of participants with a cytokine release syndrome
Cytokine release syndrome from CAR-T cells infusion to one year
Measured: From CAR-T cells infusion to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start5 Oct 2021 (estimated)
- Primary completion5 Oct 2025 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054231
- Sponsor's protocol ID
- SI-CART-IPC 2019-006
- Acronym
- SI-CART
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Profile for Patients Treated With CAR-T Cells
- ClinicalTrials.gov ID
- NCT05054231
- Acronym / sponsor ID
- SI-CART / SI-CART-IPC 2019-006
- Conditions
- Hematologic Neoplasms
- Keywords
- CAR-T cells, Immunological Profile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 5 Oct 2021 (estimated)
- Primary completion
- 5 Oct 2025 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated with CAR-T cells | Experimental | Other: Blood sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Planned injection of CAR-T cells within the scope of marketing authorization
- Signed informed consent
- French social security affiliation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood 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. | Other | Patient treated with CAR-T cells |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection in people with Hematologic Neoplasms, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between serum markers and adverse events at 1 year of the CAR-T cells infusion (time frame: 1 year after T cells infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.