Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT07120633
Brief Summary:
At present, there is a lack of relevant research on the first-line treatment of high-risk CLL patients with BTKi combined with CAR-T. Therefore, our center plans to conduct a study on the treatment of newly diagnosed high-risk CLL patients with AntiCD19 CAR-T combined with BTKi, in order to increase the uMRD rate of newly diagnosed high-risk patients, thereby improving the long-term prognosis of high-risk CLL patients and reducing the long-term medication rate of CLL patients, providing more treatment options and hope for newly diagnosed high-risk CLL patients.
Detailed Description:
First, the patient's medical history is investigated to see if the disease meets the requirements of the indications; Then inform them of the treatment process and risks, and sign an informed consent form with them. Subsequently, blood samples were taken to test for HIV and sent to the CAR-T manufacturing department for feasibility assessment of T cell production. In about 1-2 weeks, the CAR-T cell production department will evaluate the value-added capacity and transduction efficiency of the patient's cells in vitro to confirm whether the patient's peripheral blood is suitable for large-scale CAR-T cell production.
After infusion of CAR-T, subjects will undergo efficacy and toxicity assessments for 1 year, with a frequency of assessment every 3 months. The evaluation included the remission rate of minimal residual disease (MRD) in peripheral blood/bone marrow (PB/BM) and the expansion of CAR-T cells in the subjects. After completing this assessment, subjects will enter a two-year telephone follow-up and questionnaire phase to assess long-term health problems after treatment, such as recurrence of malignant tumors, and assess the subject's quality of life
Study:
NCT07120633
Study Brief:
Protocol Section:
NCT07120633