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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years, regardless of gender.

Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL, not otherwise specified) or high-grade B-cell lymphoma.

Received prior CD19-targeted chimeric antigen receptor (CAR) T-cell therapy.

Confirmed stable disease (SD) or progressive disease (PD) at the most recent imaging assessment (according to Lugano 2014 criteria) following CAR-T therapy.

Disqualifiers

Prior treatment with glofitamab resulting in disease progression.

Known severe allergic reactions to any components of the study drugs.

Active central nervous system (CNS) lymphoma involvement.

Presence of a severe, uncontrolled active infection.

Trial design

Treatments tested in this trial

  • LME-Guided Combination Therapy Regimen
  • Glofitamab Monotherapy

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai,200020, ShanghaiShanghai Municipality, China

Sponsors and collaborators

Ruijin Hospital

Lead sponsor