CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
Recruiting now · Phase 2
Conditions studied: High-risk R/R LBCL
In brief
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.
Key facts
- Study ID
- NCT07538635
- Run by
- Zhejiang Cancer Hospital
- People needed
- 20
- Starts
- 2026-04-20
- Expected to finish
- 2028-02-29
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL)
- Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline
- Meet one of the following clinical high-risk factors or molecular biological high-risk factors:
- Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression
- Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement
- ECOG 0 to 2
- Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy
- Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg/dL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL/min
- Left ventricular ejection fraction (LVEF) ≥ 40%
- Life expectancy ≥ 3 months
You may not qualify if…
- Patients who have previously received any CD19-targeted therapy
- Patients with CD19 negativity confirmed by immunohistochemistry (IHC)
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities
- Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases
- History of human immunodeficiency virus (HIV) infection
- Pregnant or lactating patients
Where it is running
- Zhejiang Cancer Hospital — Hangzhou, Zhengjiang, China (enrolling)
Full record on ClinicalTrials.gov
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