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

NCT07236203 | Recruiting

• 1 other identifier: CD19 CAR-T
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Large B-Cell Lymphoma

Keywords

CD19 CAR-T; Recurrent/Refractory Large B-Cell Lymphoma; Predictive factors for therapeutic efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment group

CAR-T

Drug: CAR-T

Interventions

CAR-T DRUG

CD19 CAR-T

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators identified patients with Relapsed/refractory large B-cell lymphoma who could be used and who were willing to receive CAR-T

You may qualify if:

• Pathological diagnosis confirmed as large B-cell lymphoma
• Patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL) after receiving second-line or above systemic treatment
• Intend to use CAR-T products approved by NMPA for the treatment of R/R LBCL.
• 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.

You may not qualify if:

• Poor patient compliance
• During pregnancy or lactation

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200231, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chuan xu Liu, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuanxu Liu, M.D

CONTACT

021-64175590; liuchuanxu@shca.org.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: November 19, 2025
• Study Start: February 29, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)