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NCT Number: NCT07609485

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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)

    Time frame: at 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ibrahim Yakoub-Agha, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: CAR-Lille

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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