Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Affiliated Hospital of Xuzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient voluntarily participates and signs the informed consent form;
Age ≥18 years old;
Confirmed as CLL/SLL according to WHO standards, and confirmed positive expression of CD19 through flow cytometry or immunohistochemical detection;
The peripheral superficial veins have smooth blood circulation and can accept intravenous infusion.
Disqualifiers
CLL patients who have undergone Richter transformation;
Patients known to have active malignant tumors involving the central nervous system. For patients who have previously suffered from central nervous system diseases and have received effective treatment, if they have completed treatment for at least 3 months before enrollment, have no evidence of symptomatic diseases, and the imaging examination shows abnormal stability, they will be considered for enrollment.
There is a history of primary malignant tumor, and it has not been relieved for at least two years. The following situations are not subject to the two-year limit: non-melanoma skin cancer, completely resected stage 1 solid tumors with low recurrence risk, radical treatment of local prostate cancer, biopsion-revealed cervical cancer in situ or smear-revealed squamous intraepithelial lesions, and completely resected breast cancer in situ.
Active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus infection;
Trial design
Design model
Single group
Treatments tested in this trial
AntiCD19 CAR-T combined with BTKi in the treatment of newly diagnosed high-risk CLL/SLL patients
Other interventionAfter 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
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: BTKi combined with CAR-T as first-line treatment for high-risk CLL/SLL patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The negative rate of minimal/measurable residual disease (MRD) within one year
Time frame
Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusionSecondary outcomes
1
Objective remission response rate
Time frame
Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusion2
Progression-free survival time
Time frame
Toxicity assessment was conducted on the subjects as planned (PB/BM assessment at 3 months, 6 months, 9 months, 12 months after CAR-T infusionSponsors and contacts
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Source ClinicalTrials.gov