NCT07609485 Identifying Cellular and Molecular Determinants of Efficacy and Resistance in Patients Undergoing CAR-T Therapy
| NCT ID | NCT07609485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2021-02-18 |
| Primary Completion | 2028-02-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2021-02-18 with a primary completion date of 2028-02-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ibrahim Yakoub-Agha, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT07609485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07609485 currently recruiting?
Yes, NCT07609485 is actively recruiting participants. Contact the research team at ibrahim.yakoubagha@chru-lille.fr for enrollment information.
Where is the NCT07609485 trial being conducted?
This trial is being conducted at Lille, France, Lille, France.
Who is sponsoring the NCT07609485 clinical trial?
NCT07609485 is sponsored by University Hospital, Lille. The principal investigator is Ibrahim Yakoub-Agha, MD,PhD at University Hospital, Lille. The trial plans to enroll 700 participants.
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