CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-… (NCT07538635) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
China20 participantsStarted 2026-04-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Patients who have previously received any CD19-targeted therapy
✕. Patients with CD19 negativity confirmed by immunohistochemistry (IHC)
What they're measuring
1
1-year PFS rate
Timeframe: From date of CAR-T infusion until the date of first documented date of disease progression or death from any cause, assessed up to 12 months
✕. 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