CClinicalTrials.gg
RecruitingNCT07609485CAR-LilleUpdated May 27, 2026

Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy

An observational study in Cancer and Hematologic Malignancy, sponsored by University Hospital, Lille. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Feb 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cancer
  • Hematologic Malignancy
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 700 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Samples from eligible patients who receives commercially available CAR-T therapy will be collected and stored at regular intervals

Inclusion criteria

  • Male or female aged ≥ 18 years and able to provide informed consent
  • Any indication,
  • Commercially available CART therapies,
  • Any conditioning.

Exclusion criteria

Exclusion Criteria:

  • Freedom privacy
  • Absence of medical coverage
  • Patients receiving CART or CAR-based cellular therapies which are not commercially available.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Treatment failure (progression and relapse) will be evaluated according to standard criteria

    Time frame: at 10 years

Secondary outcomes

  1. 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

  2. Performing Immunophenotyping and single cell sequencing of circulating CAR T cell and those infiltrating the tumor

    Time frame: at 10 years

  3. Measurement of serum cytokine levels

    Time frame: at 10 years

  4. constitution of a biological collection (biobank)

    Tests are done as needed (Immunophenotyping, DNA sequencing, cytokine measurement,..)

    Time frame: at 10 years

07

Study locations

1 of 2 sites recruiting
  • Hop Claude Huriez Chu Lille
    Lille, 59037, France
    Terminated
  • chu de Lille
    Lille, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07609485
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Feb 18, 2021
Primary completion
Feb 18, 2028 (estimated)
Completion
Feb 18, 2028 (estimated)
Last update
May 27, 2026

Study contacts

Ibrahim Yakoub-Agha, MD,PhD
Contact
ibrahim.yakoubagha@chru-lille.fr
0320445962 ext. +33
Ibrahim Yakoub-Agha, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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