CancerCAR-LilleNCT07609485
Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy
An observational study of Cancer and Hematologic Malignancy, run by University Hospital, Lille at 2 sites in France.
Trial summary
In recent years we have witnessed a breakthrough in the treatment of leukemia and lymphoma using autologous CAR-T cells that can induce durable remission in patients. Multiple approved CAR-T therapy trials, including those at our centre, have consistently yielded objective tumor regression rates in about 40% of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Hematologic Malignancy
- How many people
- 700 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Feb 2021to 18 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Samples from eligible patients who receives commercially available CAR-T therapy will be collected and stored at regular intervals
Who may be able to join
- Male or female aged ≥ 18 years and able to provide informed consent
- Any indication,
- Commercially available CART therapies,
- Any conditioning.
Who cannot join
- Freedom privacy
- Absence of medical coverage
- Patients receiving CART or CAR-based cellular therapies which are not commercially available.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Terminated
Hop Claude Huriez Chu Lille
Lille, 59037
- Recruiting
chu de Lille
Lille
ibrahim Yakoub-Agha, +33(0)3.20.44.55.51, ibrahim.yakoubagha@chru-lille.fr
About this study
Official title: Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy at the CHU, Lille: Biological Prospective Collection and Storage
In recent years we have witnessed a breakthrough in the treatment of leukemia and lymphoma using autologous CAR-T cells that can induce durable remission in patients. Multiple approved CAR-T therapy trials, including those at our centre, have consistently yielded objective tumor regression rates in about 40% of patients that have progressed after multiple previous chemo or targeted therapies. However, not all the patients respond to the therapy and rate of relapse is unfortunately common. Hence, the identification of biomarkers to track clinical activity of CAR-T and as predictive tools for patient selection is critical in our quest to develop personalized cellular therapies, where both degree and duration of response varies among different patients. For CAR-T therapy to truly live up to its promise, it is imperative to increase durable response rates. The success of CAR-T therapy not only depends in targeting antigens (e.x. CD19, BCMA) commonly expressed by malignant cells but also limited by poor persistence and trafficking of infused CAR-T cells in vivo. Hence highlighting the need to identify factors that exhibit optimal homing to the target sites and are able to persist long-term for continuous tumor surveillance. Furthermore, we lack comprehensive knowledge on how certain patients with leukemia and lymphoma achieve complete durable anti-cancer response upon CAR-T infusion whereas other either partially respond to the therapy and then relapse, or do not respond at all. Determining cellular and molecular factors that contribute to optimal homing of CAR-T cell to target sites as well as their long-term persistence will help us to design improved CAR-T based therapy against lymphoma other malignancies.
- Conditions
- Cancer, Hematologic Malignancy
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure (progression and relapse) will be evaluated according to standard criteria
Measured: at 10 years
Secondary outcomes (4)
Performing Immunophenotyping of CAR T cells and lymphocyte subsets as well as functional tests for CAR T and the corresponding tumor samples.
Measured: at 10 years
Performing Immunophenotyping and single cell sequencing of circulating CAR T cell and those infiltrating the tumor
Measured: at 10 years
Measurement of serum cytokine levels
Measured: at 10 years
constitution of a biological collection (biobank)
Tests are done as needed (Immunophenotyping, DNA sequencing, cytokine measurement,..)
Measured: at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start18 Feb 2021
- Primary completion18 Feb 2028 (estimated)
- Study completion18 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahim Yakoub-Agha, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609485
- Sponsor's protocol ID
- 2020_47
- Other IDs
- 2020-A01935-34
- Acronym
- CAR-Lille
- Status last verified
- May 2026
- First submitted
- 2 Dec 2020
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy at the CHU, Lille: Biological Prospective Collection and Storage
- ClinicalTrials.gov ID
- NCT07609485
- Acronym / sponsor ID
- CAR-Lille / 2020_47
- Conditions
- Cancer, Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 18 Feb 2028 (estimated)
- Study completion
- 18 Feb 2028 (estimated)
- First posted
- 27 May 2026 (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 recent years we have witnessed a breakthrough in the treatment of leukemia and lymphoma using autologous CAR-T cells that can induce durable remission in patients. Multiple approved CAR-T therapy trials, including those at our centre, have consistently yielded objective tumor regression rates in about 40% of patients that have progressed after multiple previous chemo or targeted therapies. However, not all the patients respond to the therapy and rate of relapse is unfortunately common. Hence, the identification of biomarkers to track clinical activity of CAR-T and as predictive tools for patient selection is critical in our quest to develop personalized cellular therapies, where both degree and duration of response varies among different patients. For CAR-T therapy to truly live up to its promise, it is imperative to increase durable response rates. The success of CAR-T therapy not only depends in targeting antigens (e.x. CD19, BCMA) commonly expressed by malignant cells but also limited by poor persistence and trafficking of infused CAR-T cells in vivo. Hence highlighting the need to identify factors that exhibit optimal homing to the target sites and are able to persist long-term for continuous tumor surveillance. Furthermore, we lack comprehensive knowledge on how certain patients with leukemia and lymphoma achieve complete durable anti-cancer response upon CAR-T infusion whereas other either partially respond to the therapy and then relapse, or do not respond at all. Determining cellular and molecular factors that contribute to optimal homing of CAR-T cell to target sites as well as their long-term persistence will help us to design improved CAR-T based therapy against lymphoma other malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples from eligible patients who receives commercially available CAR-T therapy will be collected and stored at regular intervals
Key inclusion criteria (4 listed)
- Male or female aged ≥ 18 years and able to provide informed consent
- Any indication,
- Commercially available CART therapies,
- Any conditioning.
Key exclusion criteria (3 listed)
- Freedom privacy
- Absence of medical coverage
- Patients receiving CART or CAR-based cellular therapies which are not commercially available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment failure (progression and relapse) will be evaluated according to standard criteria
Time frame: at 10 years
4 secondary outcomes
Performing Immunophenotyping of CAR T cells and lymphocyte subsets as well as functional tests for CAR T and the corresponding tumor samples.
Time frame: at 10 years
Performing Immunophenotyping and single cell sequencing of circulating CAR T cell and those infiltrating the tumor
Time frame: at 10 years
Measurement of serum cytokine levels
Time frame: at 10 years
constitution of a biological collection (biobank)
Time frame: at 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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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.
Ibrahim Yakoub-Agha, MD,PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Hematologic Malignancy, run by University Hospital, Lille at 2 sites 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Yakoub-Agha, MD,PhD (0320445962 ext. +33, ibrahim.yakoubagha@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (progression and relapse) will be evaluated according to standard criteria (time frame: at 10 years). 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 27 May 2026.