Predictive Factors for the Efficacy of CD19 CAR-T Therapy in Relapsed/Refractory Large B-Cell Lymphoma: A Clinical Study

NCT ID: NCT07236203

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2027-08-30

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.

Conditions

Large B-Cell Lymphoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment group

CAR-T

CAR-T

Intervention Type: DRUG

CD19 CAR-T

Interventions

CAR-T

CD19 CAR-T

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Rong Tao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chuan xu Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuanxu Liu, M.D

Role: CONTACT

liuchuanxu@shca.org.cn

021-64175590

Facility Contacts

Chuanxu Liu, M.D

Role: primary

liuchuanxu@shca.org.cn

021-64175590

Other Identifiers

CD19 CAR-T

Identifier Type: -

Identifier Source: org_study_id