LME-Guided Precision Combination Therapy in B-cell Lymphoma Patients After CD19 CAR-T Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
LME-Guided Combination Therapy Regimen: Participants in this arm receive a tailored combination therapy based on their baseline Lymphoma Microenvironment (LME) subtype identified via immunohistochemistry (IHC). The regimens are built on a glofitamab backbone: GC Type: Glofitamab + BCL-2 inhibitor (e.g., Lisaftoclax/Venetoclax) IN Type: Glofitamab + PD-1 inhibitor (e.g., Tislelizumab) + Lenalidomide ME Type: Glofitamab + Local Radiotherapy + BTK inhibitor (e.g., Zanubrutinib) DE Type: Glofitamab + HDAC inhibitor (e.g., Chidamide)
Glofitamab Monotherapy: Participants receive glofitamab as a single agent. Administered intravenously. Cycle 1 uses a step-up dosing schedule (e.g., 2.5mg on Day 1, 10mg on Day 8), followed by a target dose (e.g., 30mg) on Day 15 and every 3 weeks thereafter. Pretreatment with obinutuzumab 1000mg is given one week prior to the first dose.
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.
PFS is defined as the time from the date of randomization to the date of first documented disease progression (PD) or death from any cause, whichever occurs first. Disease response and progression will be assessed by a Blinded Independent Central Review (BICR) according to the Lugano 2014 classification criteria for lymphoma.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, | Shanghai | Shanghai Municipality |
More Ruijin Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07602322 on ClinicalTrials.gov ↗ ← All trials in China