Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT07236203
Brief Summary:
This is a single-center real-world study aiming to explore predictive factors for the efficacy of CAR-T therapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
Detailed Description:
This single-center, prospective, single-arm phase II observational study aims to investigate multidimensional correlations between clinical baseline characteristics, tumor biological profiles, dynamic changes in CAR-T cell subsets, immune microenvironment features, and therapeutic outcomes in patients with relapsed/refractory diffuse large B-cell lymphoma (LBCL). The study will enroll 80 participants who will receive a standardized 90-day CAR-T therapy regimen. Post-intervention management will be stratified based on the results of treatment efficacy and transplant evaluation: patients failing to achieve complete remission (CR) or exhibiting progressive disease (PD) during therapy may receive investigator-determined salvage therapies, while responders will transition to long-term follow-up. The primary endpoint is to explore predictors of CAR-T efficacy through multivariate analysis of patients' clinical baseline characteristics, tumor characteristics, CAR-T cell subsets and their dynamic changes, and immune microenvironment.
Study:
NCT07236203
Study Brief:
Protocol Section:
NCT07236203