NCT07120633

Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL

The Efficacy of AntiCD19 CAR-T Combined With BTKi in the Treatment of Newly Diagnosed High-risk CLL Patients, and to Explore Its Efficacy and Safety of Limited-term Treatment in These Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• CLL
• CAR-T Cell Therapy
• SLL

Interventions

Type	Name	Description
OTHER	AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients	After chemotherapy, the tumors of the patients in the experimental group were re-graded to determine the basic burden status of the tumors. It should include imaging diagnosis, physical examination, laboratory tests of blood, assessment of bone marrow MRD and evaluation of the toxic and side effects of chemotherapy, etc

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China