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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | CAR-T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T | Drug | CD19 CAR-T |
|
| Measure | Description | Time Frame |
|---|---|---|
| explore predictors of CAR-T efficacy | 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. | Baseline; 30 days post-infusion, 90 days post-infusion |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators identified patients with Relapsed/refractory large B-cell lymphoma who could be used and who were willing to receive CAR-T
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanxu Liu, M.D | Contact | 021-64175590 | liuchuanxu@shca.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chuan xu Liu, M.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200231 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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