Large B-Cell Lymphoma
Conditions
Keywords
CD19 CAR-T, Recurrent/Refractory Large B-Cell Lymphoma, Predictive factors for therapeutic efficacy
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.
Interventions
DRUGCAR-T
CD19 CAR-T
Sponsors
Fudan University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pathological diagnosis confirmed as large B-cell lymphoma 2. Patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL) after receiving second-line or above systemic treatment 3. Intend to use CAR-T products approved by NMPA for the treatment of R/R LBCL. 4. Understand and voluntarily sign a written informed consent form. For patients without full civil capacity, their guardians must be informed and sign the corresponding informed consent form and note the date, as for the patient himself, informed consent may be obtained based on the specific circumstances.
Exclusion criteria
1. Poor patient compliance 2. During pregnancy or lactation 3. After judgment by the researcher, the patient has other unsuitable conditions for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| explore predictors of CAR-T efficacy | Baseline; 30 days post-infusion, 90 days post-infusion | 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. |
Countries
China
Contacts
Primary ContactChuanxu Liu, M.D
Outcome results
None listed