Actively Recruiting
CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
Led by Zhejiang Cancer Hospital · Updated on 2026-05-13
20
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.
CONDITIONS
Official Title
CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of large B-cell lymphoma including DLBCL, HGBL, CNSL, PMBCL, or transformed follicular lymphoma
- Previously treated with a regimen containing anti-CD20 monoclonal antibody and anthracycline
- Presence of at least one high-risk clinical or molecular factor such as failure to respond after 4 cycles of first-line treatment, relapse within 12 months, relapse after ASCT, CNS involvement at relapse, TP53 gene mutation, or HGBL with MYC and Bcl-2 rearrangements
- ECOG performance status between 0 and 2
- Eligible for and planned to receive high-dose chemotherapy and ASCT followed by CAR-T therapy
- Liver and kidney function within specified limits (ALT/AST ≤ 3× ULN; total bilirubin ≤ 1.5 mg/dL; creatinine ≤ 1.5× ULN or creatinine clearance ≥ 30 mL/min)
- Left ventricular ejection fraction ≥ 40%
- Life expectancy of at least 3 months
You will not qualify if you...
- Previous treatment with any CD19-targeted therapy
- Negative CD19 expression confirmed by immunohistochemistry
- Active hepatitis B or C infection with viral levels above normal limits
- Uncontrolled infection, cardiovascular or cerebrovascular disease, bleeding disorders, or connective tissue diseases
- History of HIV infection
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhengjiang, China, 310022
Actively Recruiting
Research Team
X
Xi Chen
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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