Clinical Trial

LME-Guided Precision Combination Therapy in B-cell Lymphoma Patients After CD19 CAR-T Failure

Not Yet Recruiting Phase 2
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Summary
This study evaluates a personalized treatment strategy for patients with large B-cell lymphoma (LBCL) whose disease has relapsed or not responded after CD19 CAR-T cell therapy. Researchers believe that the area surrounding the tumor, called the lymphoma microenvironment (LME), plays a major role in why treatments fail. In this study, researchers will classify patients into four different LME subtypes (GC, IN, ME, or DE) using a standard lab test on their tumor samples. Patients will then be randomly assigned to one of two groups. The control group will receive a standard single-drug therapy (glofitamab). The experimental group will receive a tailored combination therapy based specifically on their tumor's LME subtype. The main hypothesis of this study is that customizing the treatment based on the tumor's microenvironment will significantly improve how long patients live without their disease getting worse (progression-free survival) compared to the standard single-drug approach.
Trial Details
NCT Number NCT07602322
Lead Sponsor Ruijin Hospital
Conditions Large B-cell Lymphoma
Enrollment 60 participants
Start Date 2026-05-14
Primary Completion 2028-05-14 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22