drugset / Trial / NCT07602322

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

NCT07602322

Phase 2 Not yet recruiting 60 enrolled Ruijin Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-14
Primary completion
2028-05-14
Completion
2028-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject APG-2575 Small molecule
Comparator Glofitamab Monoclonal antibody 30 mg Intravenous
Subject Lenalidomide Other / unclassified
Subject Tislelizumab Monoclonal antibody
Subject Tucidinostat Small molecule
Subject Venetoclax Small molecule
Subject Zanubrutinib Small molecule

Indications