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

NCT07609485 | Recruiting

• 2 other identifiers: 2020_472020-A01935-34
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer; Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

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

  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.

  at 10 years

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

  at 10 years

• Measurement of serum cytokine levels

  at 10 years

• constitution of a biological collection (biobank)

  at 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Hop Claude Huriez Chu Lille

Lille, 59037, France

TERMINATED

chu de Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ibrahim Yakoub-Agha, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Yakoub-Agha, MD,PhD

CONTACT

0320445962; ibrahim.yakoubagha@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: May 27, 2026
• Study Start: February 18, 2021
• Primary Completion (Estimated): February 18, 2028
• Study Completion (Estimated): February 18, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

FR (2)