Actively Recruiting
Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2025-08-13
50
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti CD19 CAR-T Combined With BTKi to Treat Newly Diagnosed High-risk CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily agrees to participate and signs informed consent
- Age 18 years or older
- Confirmed diagnosis of CLL or SLL by WHO standards with positive CD19 expression
- First-time patients with no prior systemic radiotherapy or chemotherapy (except short-term corticosteroids under specified conditions)
- Meet iwCLL 2018 treatment indications including progressive bone marrow failure or high-risk genetic factors
- Measurable or evaluable lesions present
- No contraindications to BTK or BCL2 inhibitors
- Adequate liver, kidney, lung, and heart function
- Suitable peripheral veins for intravenous infusion
- ECOG performance status of 0 to 2
- Expected survival longer than three months
You will not qualify if you...
- Patients with Richter transformation of CLL
- Active malignant tumors involving the central nervous system, unless stable and treated over 3 months prior
- History of primary malignant tumor unresolved for at least two years, except certain low-risk cancers
- Active infections including hepatitis B, hepatitis C, syphilis, or HIV
- Uncontrolled systemic fungal, bacterial, or viral infection within 4 weeks
- Significant cardiovascular disease within past 6 months
- Pregnant or breastfeeding women
- Allergy to large molecule biological drugs
- Recent use of systemic hormones or immunosuppressive drugs within 4 weeks (except inhaled hormones)
- Mental illness
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Actively Recruiting
Research Team
W
Wei Sang, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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